US20160338702A1 - Surgical fastener applying apparatus - Google Patents

Abstract

The present disclosure relates to surgical fastener applying apparatus for sequentially applying a plurality of surgical fasteners to body tissue. The surgical fastener applying apparatus includes a replaceable cartridge assembly receivable in a distal end portion of a cartridge receiving half-section, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of the cartridge assembly and movable from an unlocked orientation permitting assembly of an anvil half-section to the cartridge receiving half-section, to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a Divisional application of U.S. patent application Ser. No. 13/949,597, filed Jul. 24, 2013, which is a Continuation application of U.S. patent application Ser. No. 13/329,631, filed on Dec. 19, 2011, now U.S. Pat. No. 8,505,801, which is a Continuation application of U.S. patent application Ser. No. 12/841,199, filed on Jul. 22, 2010, now U.S. Pat. No. 8,091,754, which is a Continuation application of U.S. patent application Ser. No. 12/619,829, filed on Nov. 17, 2009, now U.S. Pat. No. 8,074,861, which is a Continuation application of U.S. patent application Ser. No. 12/115,612, filed on May 6, 2008, now U.S. Pat. No. 7,631,794, which is a Continuation application of U.S. patent application Ser. No. 11/699,686, filed on Jan. 29, 2007, now U.S. Pat. No. 7,631,793, which is a Continuation application of U.S. patent application Ser. No. 10/508,191, filed on Apr. 22, 2005, now U.S. Pat. No. 7,334,717, which is a 35 U.S.C. §371 National Filing of International Application Serial No. PCT/US03/08342, filed on Mar. 19, 2003, which, in turn, claims the benefit of U.S. Provisional Application Ser. No. 60/365,761, filed on Mar. 19, 2002 and U.S. Provisional Application Ser. No. 60/416,371, filed on Oct. 4, 2002, the entire contents of each of which are incorporated herein by reference.
• U.S. patent application Ser. No. 10/508,191, filed on Apr. 22, 2005, is also a Continuation-in-Part application of U.S. patent application Ser. No. 10/490,517, filed on Mar. 23, 2004, now U.S. Pat. No. 7,032,799, which is a 35 U.S.C. §371 National Filing of International Application Serial No. PCT/US02/31963, filed on Oct. 4, 2002, which, in turn, claims the benefit of U.S. Provisional Application Ser. No. 60/327,369, filed on Oct. 5, 2001, the entire contents of each of which are incorporated by reference herein.
• U.S. patent application Ser. No. 12/619,829, filed on Nov. 17, 2009, is also a Continuation-in-Part application of U.S. patent application Ser. No. 12/186,269, filed on Aug. 5, 2008, now U.S. Pat. No. 7,721,933, which is a Continuation application of U.S. patent application Ser. No. 12/011,419, filed on Jan. 24, 2008, now U.S. Pat. No. 7,568,604, which is a Continuation application of U.S. patent application Ser. No. 11/699,620, filed on Jan. 29, 2007, now U.S. Pat. No. 7,419,081, which is a Continuation application of U.S. patent application Ser. No. 11/356,912, filed on Feb. 16, 2006, now U.S. Pat. No. 7,293,685, which is a Divisional application of U.S. patent application Ser. No. 11/292,736, filed on Dec. 2, 2005, now U.S. Pat. No. 7,140,527, which is a Divisional application of U.S. patent application Ser. No. 10/399,071, filed on Apr. 10, 2003, now U.S. Pat. No. 7,055,730, which is a 35 U.S.C. §371 National Filing of International Application No. PCT/US01/32213, filed Oct. 15, 2001, which claims the benefit of U.S. Provisional Application Ser. No. 60/240,461, filed on Oct. 13, 2000, the entire contents of each of which are incorporated by this reference herein.
TECHNICAL FIELD
• The present disclosure relates to surgical fastener applying apparatus and, more particularly, to surgical fastener applying apparatus for applying a plurality of surgical fasteners to body tissue.
BACKGROUND
• Surgical apparatus or instruments, wherein tissue is first grasped or clamped between opposing jaw structures and then joined by means of surgical fasteners are well known in the art. In some such instruments a knife is provided to cut the tissue which has been joined by the fasteners. The fasteners are typically in the form of surgical staples, although, other surgical fasteners may also be utilized, such as, for example, clips or two part polymeric surgical fasteners.
• Instruments for applying surgical fasteners typically include two elongated beam members which are respectively used to capture or clamp tissue therebetween. Typically, one of the beam members carries a disposable cartridge assembly which houses a plurality of staples arranged in at least two lateral rows, while the other beam member includes an anvil which defines a surface for forming the staple legs as the staples are driven from the cartridge assembly. Where two part fasteners are used, this beam member typically carries the mating part, e.g. the receiver, to the fasteners driven from the cartridge assembly. Generally, the staple formation process is affected by the interaction between one or more longitudinally moving camming members and a series of individual staple pushers. As the camming members travel longitudinally through the cartridge carrying beam member, the individual pusher members are biased laterally, thus acting upon the staples to sequentially eject the staples from the cartridge. A knife may travel with the camming members or the individual pusher members between the staple rows to cut the tissue between the rows of formed staples. Examples of such instruments are disclosed in U.S. Pat. No. 3,079,606 and U.S. Pat. No. 3,490,675, each of which is incorporated herein in its entirety by reference.
• A later surgical apparatus or instrument, disclosed in U.S. Pat. No. 3,499,591, incorporated herein in its entirety by reference, applies a double row of staples on each side of the incision. This is accomplished by providing a cartridge assembly in which at least one camming member moves through an elongate guide path between two sets of staggered staple carrying grooves. Staple pushers are located within the grooves and are positioned in such a manner so as to be contacted by the longitudinally moving camming member to effect ejection of the staples.
• A need exists for improved surgical fastener applying apparatus, and for improved mechanisms and methods for producing improved surgical fastener applying apparatus.
SUMMARY
• The present disclosure relates to surgical fastener applying apparatus for sequentially applying a plurality of surgical fasteners to body tissue.
• According to one aspect of the present disclosure, a surgical fastener applying apparatus is disclosed including an anvil half-section having a proximal end portion and a distal end portion including an anvil which defines a fastener forming surface against which surgical fasteners are driven; a cartridge receiving half-section having a proximal end portion and a distal end portion, the cartridge receiving half-section being configured and adapted to releasably mate with the anvil half-section, the surgical fastener applying apparatus having an assembled configuration wherein the anvil half-section and the cartridge receiving half-section are positioned in juxtaposed alignment with each other, the anvil half-section and the cartridge receiving half-section being relatively movable from an unclamped position to a fully clamped position to clamp tissue therebetween, the cartridge half-section including a pivotable clamping lever, wherein movement of the clamping lever from a first position to a second position moves the cartridge receiving and anvil half-sections to the fully clamped position; and a replaceable cartridge assembly receivable in the distal end portion of the cartridge receiving half-section. The cartridge assembly includes an upper surface and a plurality of surgical staples and surgical staple pushers, the surgical staples being ejectable by the pusher members from the cartridge assembly through openings in the upper surface, the cartridge assembly defining at least one slot for receiving at least one knife therein, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of the cartridge assembly and movable from an unlocked orientation permitting assembly of the anvil half-section, to the cartridge receiving half-section to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.
• In one embodiment, the safety lockout is biased from the unlocked orientation to the locked orientation. Preferably, the safety lockout is biased by a spring. It is envisioned that the safety lockout includes a transverse horizontal surface formed on the underside thereof and which is configured and adapted to engage a member formed on a surface of the at least one knife. The transverse horizontal surface and the member of the at least one knife are configured and dimensioned such that when the at least one knife is displaced in a distal direction, the member of the at least one knife disengages from the transverse horizontal surface. It is envisioned that the member of the at least one knife is a hook.
• In another embodiment, the cartridge receiving half-section includes a loading and lockout mechanism operatively associated therewith, the loading and lockout mechanism being configured and adapted to facilitate loading of the cartridge assembly to the to the cartridge receiving half-section and to prevent firing of the surgical fastener applying apparatus until the cartridge assembly is properly assembled with cartridge receiving half-section. It is envisioned that the loading and lockout mechanism includes a rocker pivotably mounted to the cartridge receiving half-section, the rocker having a locked-out position which prevents firing of the surgical fastener applying apparatus and a firing position which permits firing of the surgical fastener applying apparatus, the rocker defining a downwardly extending blocking surface which, when in the locked-out position, the rocker engages a cam bar and prevents displacement of the cam bar in a distal direction and when in the firing position the rocker disengages the cam bar and allows the cam bar to be displaced distally.
• It is envisioned that the rocker defines an upper edge blocking surface, wherein when the rocker is in the locked-out position the upper edge blocking surface engages a knife actuating bar and prevents displacement of the knife actuating bar in a distal direction, and when the rocker is in the firing position the upper edge blocking surface disengages the knife actuating bar and allows the knife actuating bar to be displaced distally. The rocker is preferably biased to the locked-out position. The rocker is preferably adapted to be pivoted to the firing position when the anvil half-section is coupled to the cartridge receiving half-section.
• In yet another embodiment, the surgical fastener applying apparatus further includes a gap adjustment mechanism operatively associated between the anvil half-section and the cartridge receiving half-section, wherein the gap adjustment mechanism is configured and adapted to vary the size of a gap between the distal end portions of the anvil half-section and the cartridge receiving half-section. It is envisioned that the gap adjustment mechanism includes a cam positioned between the anvil half-section and the cartridge receiving half-section when in the assembled condition, wherein manipulation of the cam results in the variation of the size of the gap between the distal ends of the anvil half-section and the cartridge receiving half-section.
• Preferably, the cam includes a forward portion, a body portion and a rearward portion, wherein the body portion of the cam defines a central rotational axis and wherein the forward and rearward portions share a common axis which is spaced a distance from the central rotational axis. It is envisioned that body portion is rotationally disposed within apertures formed in the anvil half section and the forward and rearward portions rest against respective surfaces of opposed hinge plates extending from the cartridge receiving half-section, wherein rotation of the cam about the central rotational axis results in the forward and rearward portions of the cam to displace the cartridge receiving half-section.
• It is envisioned that the gap adjustment mechanism includes a cam lock configured and adapted to engage the body portion of the cam and to prevent rotation of the cam after adjustment of the gap.
• In another embodiment, the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining an access channel formed therein, each access channel being is configured and dimensioned to receive a respective mounting boss extending laterally from the anvil half-section, such that as the clamping lever is approximated toward the cartridge receiving half-section, the access channels guide the mounting bosses therethrough to properly assemble the anvil half-section with the cartridge receiving half-section.
• Preferably, when the anvil receiving half-section is oriented in the horizontal plane and the clamping lever is in the first position, the opening to each access channel can be vertically accessed. It is envisioned that each access channel is generally orthogonal to the cartridge receiving half-section. It is further envisioned that each access channel faces angularly relative to the cartridge receiving half-section.
• In yet another embodiment, the proximal end of the cartridge receiving half-section includes a pair of upstanding juxtaposed pivot plates each including a pin receiving slot formed therein. The proximal end of the anvil half-section includes a pin extending laterally from either side thereof, the pin being positionable within the pin receiving slots formed in the pivot plates of the cartridge receiving half-section. The pin preferably extends laterally from the proximal end of the anvil half-section is non-round in cross-section, and wherein the shape of the pin cooperates with the pin receiving slot to limit the angle at which the anvil half-section can be approximated to the cartridge receiving half-section in order to effectuate proper assembly. It is envisioned that the angle is less than about 15°. Preferably, the pin has a pear shape cross-section defined by a larger lower portion and a smaller upper portion.
• In another embodiment, the surgical fastener applying apparatus includes a firing slide operatively associated with the cartridge receiving half-section, the firing slide including a firing lever pivotably coupled thereto, wherein the firing lever is adapted to enable the surgical fastener applying apparatus to be fired from either side thereof. The firing slide includes, in one embodiment, a pair of cam bars configured and adapted to sequentially expel the plurality of fasteners in a direction transverse to the direction of movement of the pair of cam bars, and a knife actuating bar positioned between the pair of cam bars for displacing the knife in the direction of movement of the cam bars.
• The firing slide includes, in another embodiment, a slide block having a hub extending therefrom for receipt in a pivot hole formed in the firing lever; and a pedal having a pin reciprocally received in and extending from a hole formed in the slide block, such that as the firing slide is displaced in a distal direction the pin from the pedal extends into a recess formed in the firing lever to thereby prevent the firing lever from thereafter pivoting about the hub of the slide block.
• In another aspect of the present disclosure, a surgical fastener applying apparatus is disclosed including an anvil half-section; a cartridge receiving half-section configured and adapted to releasably mate with the anvil half-section; and a gap adjustment mechanism operatively associated between the anvil half-section and the cartridge receiving half-section, wherein the gap adjustment mechanism is configured and adapted to vary the size of the gap between the distal end portions of the anvil half-section and the cartridge receiving half-section.
• In one embodiment, the gap adjustment mechanism includes a cam positioned between the anvil half-section and the cartridge receiving half-section when in the assembled condition, wherein manipulation of the cam results in the variation of the size of the gap between the distal ends of the anvil half-section and the cartridge receiving half-section. It is envisioned that the cam includes a forward portion, a body portion and a rearward portion, wherein the body portion of the cam defines a central rotational axis and wherein the forward and rearward portions share a common axis which is spaced a distance from the central rotational axis. The body portion is rotationally disposed within apertures formed in the anvil half section and the forward and rearward portions rest against respective surfaces of opposed hinge plates extending from the cartridge receiving half-section, wherein rotation of the cam about the central rotational axis results in the forward and rearward portions of the cam to displace the cartridge receiving half-section.
• It is envisioned that the gap adjustment mechanism includes a cam lock configured and adapted to engage the body portion of the cam and to prevent rotation of the cam after adjustment of the gap.
• In another embodiment, the cartridge receiving half-section includes a loading and lockout mechanism operatively associated therewith, the loading and lockout mechanism being configured and adapted to facilitate loading of the cartridge assembly to the to the cartridge receiving half-section and to prevent firing of the surgical fastener applying apparatus until the cartridge assembly is properly loaded onto cartridge receiving half-section. The loading and lockout mechanism includes a rocker pivotably mounted to the cartridge receiving half-section, the rocker having a locked-out position which prevents firing of the surgical fastener applying apparatus and a firing position which permits firing of the surgical fastener applying apparatus, when in the locked-out position, the rocker engages a cam bar and prevents displacement of the cam bar in a distal direction and when in the firing position the rocker disengages the cam bar and allows the cam bar to be displaced distally.
• It is envisioned that the rocker defines an upper edge blocking surface, wherein when the rocker is in the locked-out position the upper edge blocking surface engages a knife actuating bar and prevents displacement of the knife actuating bar in a distal direction and when the rocker is in the firing position the upper edge blocking surface disengages the knife actuating bar and allows the knife actuating bar to be displaced distally. Preferably, the rocker is biased to the locked-out position. It is contemplated that the rocker is pivoted to the firing position when the anvil half-section is coupled to the cartridge receiving half-section.
• In another embodiment, the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining an access channel formed therein, wherein each access channel is configured and dimensioned to receive a respective mounting boss extending laterally from the anvil half-section, wherein as the clamping lever is approximated toward the cartridge receiving half-section, the access channels guide the mounting bosses therethrough to properly mate the anvil half-section with the cartridge receiving half-section.
• Preferably, when the anvil receiving half-section is oriented in the horizontal plane and the clamping lever is in the first position, the opening to each access channel can be vertically accessed. It is envisioned that each access channel is generally orthogonal to the cartridge receiving half-section. It is further envisioned that each access channel faces angularly relative to the cartridge receiving half-section.
• In another embodiment, the proximal end of the cartridge receiving half-section includes a pair of upstanding juxtaposed pivot plates each including a pin receiving slot formed therein. The proximal end of the anvil half-section includes a pin extending laterally from either side thereof, wherein the pin at the proximal end of the anvil half-section is positionable within the pin receiving slots formed in the pivot plates of the cartridge receiving half-section.
• The pin extending laterally from the proximal end of the anvil half-section is non-round, and wherein the pin limits the angle at which the anvil half-section can be approximated to the cartridge receiving half-section in order to effectuate proper assembly. Preferably, the angle is less than about 15°. It is envisioned that the pin has a pear shape cross-section defined by a larger lower portion and a smaller upper portion.
• In another embodiment, the surgical fastener applying apparatus includes a firing slide operatively associated with the cartridge receiving half-section, the firing slide including a firing lever pivotably coupled thereto, wherein the firing lever enables the surgical fastener applying apparatus to be fired from either side thereof. It is envisioned that the firing slide includes, in one embodiment, a pair of cam bars configured and adapted to sequentially expel the plurality of fasteners in a direction transverse to the direction of movement of the pair of cam bars, a knife actuating bar positioned between the pair of cam bars for displacing the knife in the direction of movement of the cam bars.
• It is envisioned that the firing slide includes, in another embodiment, a slide block having a hub extending therefrom for receipt in a pivot hole formed in the firing lever, and a pedal having a pin reciprocally received in a hole formed in the slide block, wherein as the firing slide is displaced in a distal direction the pin from the pedal extends into a recess formed in the firing lever to thereby prevent the firing lever from thereafter pivoting about the hub of the slide block.
• According to another aspect of the present disclosure, a surgical fastener applying apparatus is disclosed which includes an anvil half-section; and a cartridge receiving half-section configured and adapted to releasably mate with the anvil half-section, wherein the cartridge receiving half-section includes a loading and lockout mechanism operatively associated therewith, the loading and lockout mechanism being configured and adapted to facilitate loading of the cartridge assembly to the to the cartridge receiving half-section and to prevent firing of the surgical fastener applying apparatus until the cartridge assembly is properly loaded onto cartridge receiving half-section.
• It is envisioned that the loading and lockout mechanism includes a rocker pivotably mounted to the cartridge receiving half-section, the rocker having a locked-out position which prevents firing of the surgical fastener applying apparatus and a firing position which permits firing of the surgical fastener applying apparatus, when in the locked-out position, the rocker engages a cam bar and prevents displacement of the cam bar in a distal direction and when in the firing position the rocker disengages the cam bar and allows the cam bar to be displaced distally.
• The rocker defines an upper edge blocking surface, wherein when the rocker is in the locked-out position the upper edge blocking surface engages a knife actuating bar and prevents displacement of the knife actuating bar in a distal direction and when the rocker is in the firing position the upper edge blocking surface disengages the knife actuating bar and allows the knife actuating bar to be displaced distally. It is envisioned that the rocker is biased to the locked-out position. Preferably, the rocker is pivoted to the firing position when the anvil half-section is coupled to the cartridge receiving half-section.
• It is envisioned that the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining an access channel formed therein, wherein each access channel is configured and dimensioned to receive a respective mounting boss extending laterally from the anvil half-section, wherein as the clamping lever is approximated toward the cartridge receiving half-section, the access channels guide the mounting bosses therethrough to properly mate the anvil half-section with the cartridge receiving half-section.
• Preferably, when the anvil receiving half-section is oriented in the horizontal plane and the clamping lever is in the first position, the opening to each access channel can be vertically accessed. It is envisioned that each access channel is generally orthogonal to the cartridge receiving half-section. It is further envisioned that each access channel faces angularly relative to the cartridge receiving half-section.
• In another embodiment, the proximal end of the cartridge receiving half-section includes a pair of upstanding juxtaposed pivot plates each including a pin receiving slot formed therein. The proximal end of the anvil half-section includes a pin extending laterally from either side thereof, and wherein the pin at the proximal end of the anvil half-section is positionable within the pin receiving slots formed in the pivot plates of the cartridge receiving half-section.
• It is envisioned that the pin extending laterally from the proximal end of the anvil half-section is non-round, wherein the pin limits the angle at which the anvil half-section can be approximated to the cartridge receiving half-section in order to effectuate proper assembly. Preferably, the angle is less than about 15°. It is envisioned that the pin has a pear shape cross-section defined by a larger lower portion and a smaller upper portion.
• In another embodiment, the surgical fastener applying apparatus includes a firing slide operatively associated with the cartridge receiving half-section, the firing slide including a firing lever pivotably coupled thereto, wherein the firing lever enables the surgical fastener applying apparatus to be fired from either side thereof.
• The firing slide includes, in one embodiment, a pair of cam bars configured and adapted to sequentially expel the plurality of fasteners in a direction transverse to the direction of movement of the pair of cam bars, a knife actuating bar positioned between the pair of cam bars for displacing the knife in the direction of movement of the cam bars.
• The firing slide includes, in another embodiment, a slide block having a hub extending therefrom for receipt in a pivot hole formed in the firing lever; and a pedal having a pin reciprocally received in a hole formed in the slide block, wherein as the firing slide is displaced in a distal direction the pin from the pedal extends into a recess formed in the firing lever to thereby prevent the firing lever from thereafter pivoting about the hub of the slide block.
• It is envisioned that the surgical fastener applying apparatus further includes a replaceable cartridge assembly receivable in the distal end portion of the cartridge receiving half-section, the cartridge assembly having an upper surface and a plurality of surgical staples and surgical staple pushers, the surgical staples being ejectable by the pusher members from the cartridge assembly through openings in the upper surface, the cartridge assembly defining at least one slot for receiving at least one knife therein, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of cartridge assembly and movable from an unlocked orientation permitting assembly of the anvil half-section to the cartridge receiving half-section to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.
• The safety lockout is biased from the unlocked orientation to the locked orientation. Preferably, the safety lockout is biased by a spring. The safety lockout includes a transverse horizontal surface formed on the underside thereof which transverse horizontal surface is configured and adapted to engage a hook formed on an upper surface of the at least one knife. The transverse horizontal surface and the hook are configured and dimensioned such that when the at least one knife is displaced in a distal direction, the hook disengages from the transverse horizontal surface.
• In yet another aspect of the present disclosure, a surgical fastener applying apparatus is disclosed which includes an anvil half-section; and a cartridge receiving half-section configured and adapted to releasably mate with the anvil half-section, the cartridge half-section including a pivotable clamping lever, wherein movement of the clamping lever from a first position to a second position moves the cartridge receiving and anvil half-sections to the fully clamped position, and wherein the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining an access channel formed therein, wherein each access channel is configured and dimensioned to receive a respective mounting boss extending laterally from the anvil half-section, wherein as the clamping lever is approximated toward the cartridge receiving half-section, the access channels guide the mounting bosses therethrough to properly mate the anvil half-section with the cartridge receiving half-section.
• Preferably, when the anvil receiving half-section is oriented in the horizontal plane and the clamping lever is in the first position, the opening to each access channel can be vertically accessed. It is envisioned that each access channel is generally orthogonal to the cartridge receiving half-section. It is further envisioned that each access channel faces angularly relative to the cartridge receiving half-section.
• It is envisioned that the proximal end of the cartridge receiving half-section includes a pair of upstanding juxtaposed pivot plates each including a pin receiving slot formed therein. The proximal end of the anvil half-section includes a pin extending laterally from either side thereof, and wherein the pin at the proximal end of the anvil half-section is positionable within the pin receiving slots formed in the pivot plates of the cartridge receiving half-section. The pin preferably extends laterally from the proximal end of the anvil half-section is non-round, wherein the pin limits the angle at which the anvil half-section can be approximated to the cartridge receiving half-section in order to effectuate proper assembly. It is envisioned that the angle is less than about 15°. Preferably, the pin has a pear shape cross-section defined by a larger lower portion and a smaller upper portion.
• It is further envisioned that the surgical fastener applying apparatus includes a firing slide operatively associated with the cartridge receiving half-section, the firing slide including a firing lever pivotably coupled thereto, wherein the firing lever enables the surgical fastener applying apparatus to be fired from either side thereof.
• It is contemplated that the firing slide includes, in one embodiment, a pair of cam bars configured and adapted to sequentially expel the plurality of fasteners in a direction transverse to the direction of movement of the pair of cam bars, a knife actuating bar positioned between the pair of cam bars for displacing the knife in the direction of movement of the cam bars.
• It is further contemplated that the firing slide includes, in another embodiment, a slide block having a hub extending therefrom for receipt in a pivot hole formed in the firing lever; and a pedal having a pin reciprocally received in a hole formed in the slide block, wherein as the firing slide is displaced in a distal direction the pin from the pedal extends into a recess formed in the firing lever to thereby prevent the firing lever from thereafter pivoting about the hub of the slide block.
• It is envisioned that the surgical fastener applying apparatus includes a replaceable cartridge assembly receivable in the distal end portion of the cartridge receiving half-section, the cartridge assembly having an upper surface and a plurality of surgical staples abutting surgical staple pushers, the surgical staples being ejectable from the cartridge assembly through openings in the upper surface, the cartridge assembly defining at least one slot for receiving at least one knife therein, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of cartridge assembly and movable from an unlocked orientation permitting assembly of the anvil half-section to the cartridge receiving half-section to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.
• The safety lockout is biased from the unlocked orientation to the locked orientation. Preferably, the safety lockout is biased by a spring. The safety lockout includes a transverse horizontal surface formed on the underside thereof which transverse horizontal surface is configured and adapted to engage a hook formed on an upper surface of the at least one knife. It is envisioned that the transverse horizontal surface and the hook are configured and dimensioned such that when the at least one knife is displaced in a distal direction, the hook disengages from the transverse horizontal surface.
• It is envisioned that the surgical fastener applying apparatus further includes a replaceable cartridge assembly receivable in the distal end portion of the cartridge receiving half-section, the cartridge assembly having an upper surface and a plurality of surgical staples and surgical staple pushers, the surgical staples being ejectable by the pusher members from the cartridge assembly through openings in the upper surface, the cartridge assembly defining at least one slot for receiving at least one knife therein, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of the cartridge assembly and movable from an unlocked orientation permitting assembly of the anvil half-section, to the cartridge receiving half-section to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.
• It is envisioned that the cartridge receiving half-section includes a loading and lockout mechanism operatively associated therewith, the loading and lockout mechanism being configured and adapted to facilitate loading of the cartridge assembly to the to the cartridge receiving half-section and to prevent firing of the surgical fastener applying apparatus until the cartridge assembly is properly loaded onto cartridge receiving half-section.
• The loading and lockout mechanism includes a rocker pivotably mounted to the cartridge receiving half-section, the rocker having a locked-out position which prevents firing of the surgical fastener applying apparatus and a firing position which permits firing of the surgical fastener applying apparatus, when in the locked-out position, the rocker engages a cam bar and prevents displacement of the cam bar in a distal direction and when in the firing position the rocker disengages the cam bar and allows the cam bar to be displaced distally. The rocker defines an upper edge blocking surface, wherein when the rocker is in the locked-out position the upper edge blocking surface engages a knife actuating bar and prevents displacement of the knife actuating bar in a distal direction and when the rocker is in the firing position the upper edge blocking surface disengages the knife actuating bar and allows the knife actuating bar to be displaced distally. Preferably, the rocker is biased to the locked-out position. The rocker is pivoted to the firing position when the anvil half-section is coupled to the cartridge receiving half-section.
• It is envisioned that surgical fastener applying apparatus further includes a gap adjustment mechanism operatively associated between the anvil half-section and the cartridge receiving half-section, wherein the gap adjustment mechanism is configured and adapted to vary the size of a gap between the distal end portions of the anvil half-section and the cartridge receiving half-section.
• The gap adjustment mechanism includes a cam positioned between the anvil half-section and the cartridge receiving half-section when in the mated condition, wherein manipulation of the cam results in the variation of the size of the gap between the distal ends of the anvil half-section and the cartridge receiving half-section. It is envisioned that the cam includes a forward portion, a body portion and a rearward portion, wherein the body portion of the cam defines a central rotational axis and wherein the forward and rearward portions share a common axis which is spaced a distance from the central rotational axis. The body portion is rotationally disposed within apertures formed in the anvil half section and the forward and rearward portions rest against respective shoulders of opposed hinge plates extending from the cartridge receiving half-section, wherein rotation of the cam about the central rotational axis results in the forward and rearward portions of the cam to displace the cartridge receiving half-section.
• According to still another aspect of the present disclosure, a surgical fastener applying apparatus is disclosed which includes an anvil half-section; and a cartridge receiving half-section configured and adapted to releasably mate with the anvil half-section, wherein the proximal end of the cartridge receiving half-section includes a pair of upstanding juxtaposed pivot plates each including a pin receiving slot formed therein.
• It is envisioned that the proximal end of the anvil half-section includes a pin extending laterally from either side thereof, wherein the pin at the proximal end of the anvil half-section is positionable within the pin receiving slots formed in the pivot plates of the cartridge receiving half-section. Preferably, the pin extending laterally from the proximal end of the anvil half-section is non-round, and wherein the pin limits the angle at which the anvil half-section can be approximated to the cartridge receiving half-section in order to effectuate proper assembly. The angle is preferably less than about 15°. Preferably, the pin has a pear shape cross-section defined by a larger lower portion and a smaller upper portion.
• It is envisioned that the surgical fastener applying apparatus includes a firing slide operatively associated with the cartridge receiving half-section, the firing slide including a firing lever pivotably coupled thereto, wherein the firing lever enables the surgical fastener applying apparatus to be fired from either side thereof.
• It is further envisioned that, the firing slide includes, in one embodiment, a pair of cam bars configured and adapted to sequentially expel the plurality of fasteners in a direction transverse to the direction of movement of the pair of cam bars, a knife actuating bar positioned between the pair of cam bars for displacing the knife in the direction of movement of the cam bars.
• It is envisioned that, the firing slide includes, in yet another embodiment, a slide block having a hub extending therefrom for receipt in a pivot hole formed in the firing lever; and a pedal having a pin reciprocally received in a hole formed in the slide block, wherein as the firing slide is displaced in a distal direction the pin from the pedal extends into a recess formed in the firing lever to thereby prevent the firing lever from thereafter pivoting about the hub of the slide block.
• In one embodiment, the surgical fastener applying apparatus further includes a replaceable cartridge assembly receivable in the distal end portion of the cartridge receiving half-section, the cartridge assembly having an upper surface and a plurality of surgical staples and surgical staple pushers, the surgical staples being ejectable by the pusher members from the cartridge assembly through openings in the upper surface, the cartridge assembly defining at least one slot for receiving at least one knife therein, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of cartridge assembly and movable from an unlocked orientation permitting assembly of the anvil half-section to the cartridge receiving half-section to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.
• The safety lockout is preferably biased from the unlocked orientation to the locked orientation. It is envisioned that the safety lockout is biased by a spring. The safety lockout includes a transverse horizontal surface formed on the underside thereof which transverse horizontal surface is configured and adapted to engage a hook formed on an upper surface of the at least one knife. The transverse horizontal surface and the hook are configured and dimensioned such that when the at least one knife is displaced in a distal direction, the hook disengages from the transverse horizontal surface.
• It is envisioned that the cartridge receiving half-section includes a loading and lockout mechanism operatively associated therewith, the loading and lockout mechanism being configured and adapted to facilitate loading of the cartridge assembly to the to the cartridge receiving half-section and to prevent firing of the surgical fastener applying apparatus until the cartridge assembly is properly loaded onto cartridge receiving half-section. The loading and lockout mechanism includes a rocker pivotably mounted to the cartridge receiving half-section, the rocker having a locked-out position which prevents firing of the surgical fastener applying apparatus and a firing position which permits firing of the surgical fastener applying apparatus, when in the locked-out position, the rocker engages a cam bar and prevents displacement of the cam bar in a distal direction and when in the firing position the rocker disengages the cam bar and allows the cam bar to be displaced distally.
• The rocker defines an upper edge blocking surface, wherein when the rocker is in the locked-out position the upper edge blocking surface engages a knife actuating bar and prevents displacement of the knife actuating bar in a distal direction and when the rocker is in the firing position the upper edge blocking surface disengages the knife actuating bar and allows the knife actuating bar to be displaced distally. The rocker is preferably biased to the locked-out position. Preferably, the rocker is pivoted to the firing position when the anvil half-section is coupled to the cartridge receiving half-section.
• In another embodiment, the surgical fastener applying apparatus includes a gap adjustment mechanism operatively associated between the anvil half-section and the cartridge receiving half-section, wherein the gap adjustment mechanism is configured and adapted to vary the size of a gap between the distal end portions of the anvil half-section and the cartridge receiving half-section. The gap adjustment mechanism includes a cam positioned between the anvil half-section and the cartridge receiving half-section when in the mated condition, wherein manipulation of the cam results in the variation of the size of the gap between the distal ends of the anvil half-section and the cartridge receiving half-section.
• The cam includes a forward portion, a body portion and a rearward portion, wherein the body portion of the cam defines a central rotational axis and wherein the forward and rearward portions share a common axis which is spaced a distance from the central rotational axis. The body portion is rotationally disposed within apertures formed in the anvil half section and the forward and rearward portions rest against respective shoulders of opposed hinge plates extending from the cartridge receiving half-section, wherein rotation of the cam about the central rotational axis results in the forward and rearward portions of the cam to displace the cartridge receiving half-section. Preferably, the gap adjustment mechanism includes a cam lock configured and adapted to engage the body portion of the cam and to prevent rotation of the cam after adjustment of the gap.
• It is envisioned that the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining an access channel formed therein, wherein each access channel is configured and dimensioned to receive a respective mounting boss extending laterally from the anvil half-section, wherein as the clamping lever is approximated toward the cartridge receiving half-section, the access channels guide the mounting bosses therethrough to properly mate the anvil half-section with the cartridge receiving half-section.
• Preferably, when the anvil receiving half-section is oriented in the horizontal plane and the clamping lever is in the first position, the opening to each access channel can be vertically accessed. It is envisioned that each access channel is generally orthogonal to the cartridge receiving half-section. It is further envisioned that each access channel faces angularly relative to the cartridge receiving half-section.
• In yet another aspect of the present disclosure, a surgical fastener applying apparatus is provided which includes an anvil half-section, a cartridge receiving half-section configured and adapted to releasably mate with the anvil half-section, a replaceable cartridge assembly receivable in the distal end portion of the cartridge receiving half-section, and a firing slide operatively associated with the cartridge receiving half-section, the firing slide including a firing lever pivotably coupled thereto, wherein the firing lever enables the surgical fastener applying apparatus to be fired from either side thereof.
• It is envisioned that the firing slide includes a pair of cam bars configured and adapted to sequentially expel the plurality of fasteners in a direction transverse to the direction of movement of the pair of cam bars, a knife actuating bar positioned between the pair of cam bars for displacing the knife in the direction of movement of the cam bars.
• The firing slide includes, in another embodiment, a slide block having a hub extending therefrom for receipt in a pivot hole formed in the firing lever; and a pedal having a pin reciprocally received in a hole formed in the slide block, wherein as the firing slide is displaced in a distal direction the pin from the pedal extends into a recess formed in the firing lever to thereby prevent the firing lever from thereafter pivoting about the hub of the slide block.
• It is envisioned that the surgical fastener applying apparatus further includes a replaceable cartridge assembly receivable in the distal end portion of the cartridge receiving half-section, the cartridge assembly having an upper surface and a plurality of surgical staples and surgical staple pushers, the surgical staples being ejectable by the pusher members from the cartridge assembly through openings in the upper surface, the cartridge assembly defining at least one slot for receiving at least one knife therein, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of the cartridge assembly and movable from an unlocked orientation permitting assembly of the anvil half-section, to the cartridge receiving half-section to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.
• Preferably, the safety lockout is biased by a spring. The safety lockout includes a transverse horizontal surface formed on the underside thereof which transverse horizontal surface is configured and adapted to engage a hook formed on an upper surface of the at least one knife. The transverse horizontal surface and the hook are configured and dimensioned such that when the at least one knife is displaced in a distal direction, the hook disengages from the transverse horizontal surface.
• It is envisioned that the cartridge receiving half-section includes a loading and lockout mechanism operatively associated therewith, the loading and lockout mechanism being configured and adapted to facilitate loading of the cartridge assembly to the to the cartridge receiving half-section and to prevent firing of the surgical fastener applying apparatus until the cartridge assembly is properly loaded onto cartridge receiving half-section.
• The loading and lockout mechanism includes a rocker pivotably mounted to the cartridge receiving half-section, the rocker having a locked-out position which prevents firing of the surgical fastener applying apparatus and a firing position which permits firing of the surgical fastener applying apparatus, when in the locked-out position, the rocker engages a cam bar and prevents displacement of the cam bar in a distal direction and when in the firing position the rocker disengages the cam bar and allows the cam bar to be displaced distally.
• The rocker defines an upper edge blocking surface, wherein when the rocker is in the locked-out position the upper edge blocking surface engages a knife actuating bar and prevents displacement of the knife actuating bar in a distal direction and when the rocker is in the firing position the upper edge blocking surface disengages the knife actuating bar and allows the knife actuating bar to be displaced distally. Preferably, the rocker is biased to the locked-out position. The rocker is pivoted to the firing position when the anvil half-section is coupled to the cartridge receiving half-section.
• It is envisioned that the surgical fastener applying apparatus further includes a gap adjustment mechanism operatively associated between the anvil half-section and the cartridge receiving half-section, wherein the gap adjustment mechanism is configured and adapted to vary the size of a gap between the distal end portions of the anvil half-section and the cartridge receiving half-section. The gap adjustment mechanism includes a cam positioned between the anvil half-section and the cartridge receiving half-section when in the mated condition, wherein manipulation of the cam results in the variation of the size of the gap between the distal ends of the anvil half-section and the cartridge receiving half-section.
• The cam includes a forward portion, a body portion and a rearward portion, wherein the body portion of the cam defines a central rotational axis and wherein the forward and rearward portions share a common axis which is spaced a distance from the central rotational axis. The body portion is rotationally disposed within apertures formed in the anvil half section and the forward and rearward portions rest against respective shoulders of opposed hinge plates extending from the cartridge receiving half-section, wherein rotation of the cam about the central rotational axis results in the forward and rearward portions of the cam to displace the cartridge receiving half-section. Preferably, the gap adjustment mechanism includes a cam lock configured and adapted to engage the body portion of the cam and to prevent rotation of the cam after adjustment of the gap.
• It is envisioned that the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining an access channel formed therein, wherein each access channel is configured and dimensioned to receive a respective mounting boss extending laterally from the anvil half-section, wherein as the clamping lever is approximated toward the cartridge receiving half-section, the access channels guide the mounting bosses therethrough to properly mate the anvil half-section with the cartridge receiving half-section.
• Preferably, when the anvil receiving half-section is oriented in the horizontal plane and the clamping lever is in the first position, the opening to each access channel can be vertically accessed. It is envisioned that each access channel is generally orthogonal to the cartridge receiving half-section. It is further envisioned that each access channel faces angularly relative to the cartridge receiving half-section.
• In one embodiment, the proximal end of the cartridge receiving half-section includes a pair of upstanding juxtaposed pivot plates each including a pin receiving slot formed therein. The proximal end of the anvil half-section includes a pin extending laterally from either side thereof, and wherein the pin at the proximal end of the anvil half-section is positionable within the pin receiving slots formed in the pivot plates of the cartridge receiving half-section. The pin extending laterally from the proximal end of the anvil half-section is non-round, wherein the pin limits the angle at which the anvil half-section can be approximated to the cartridge receiving half-section in order to effectuate proper assembly. It is contemplated that the angle is less than about 15°. Preferably, the pin has a pear shape cross-section defined by a larger lower portion and a smaller upper portion.
• In yet another aspect of the present disclosure, a staple cartridge assembly receivable in a distal end portion of cartridge receiving half-section of a surgical stapler is disclosed. The staple cartridge assembly includes a safety lockout pivotably disposed along an upper surface of the cartridge assembly and movable from an unblocked orientation permitting assembly of an anvil half-section to the cartridge receiving half-section, to a locked orientation preventing assembly of the anvil half-section with the cartridge receiving half-section.
• The safety lockout is biased from the unlocked orientation to the locked orientation. The safety lockout is biased by a spring. The safety lockout includes a transverse horizontal surface formed on the underside thereof and which is configured and adapted to engage a member formed on a surface of the at least one knife. Preferably, the transverse horizontal surface and the member of the at least one knife are configured and dimensioned such that when the at least one knife is displaced in a distal direction, the member of the at least one knife disengages from the transverse horizontal surface. It is envisioned that the at least one knife is a hook.
• It is envisioned that the staple cartridge assembly apparatus further includes a loading and lockout mechanism operatively associated therewith, the loading and lockout mechanism being configured and adapted to facilitate loading of the cartridge assembly to the to the cartridge receiving half-section and to prevent firing of the surgical fastener applying apparatus until the cartridge assembly is properly assembly with cartridge receiving half-section. The loading and lockout mechanism includes a rocker pivotably mounted to the cartridge receiving half-section, the rocker having a locked-out position which prevents firing of the surgical fastener applying apparatus and a firing position which permits firing of the surgical fastener applying apparatus, the rocker defining a downwardly extending blocking surface which, when in the locked-out position, the rocker engages a cam bar and prevents displacement of the cam bar in a distal direction and when in the firing position the rocker disengages the cam bar and allows the cam bar to be displaced distally.
• The rocker defines an upper edge blocking surface, wherein when the rocker is in the locked-out position the upper edge blocking surface engages a knife actuating bar and prevents displacement of the knife actuating bar in a distal direction, and when the rocker is in the firing position the upper edge blocking surface disengages the knife actuating bar and allows the knife actuating bar to be displaced distally. Preferably, the rocker is biased to the locked-out position. The rocker is adapted to be pivoted to the firing position when the anvil half-section is coupled to the cartridge receiving half-section.
• It is envisioned that the staple cartridge assembly includes a series of finger grips formed along an upper side surface near a proximal end thereof.
• In yet another aspect of the present disclosure, a surgical fastener applying apparatus is disclosed which includes an anvil half-section; and a cartridge receiving half-section configured and adapted to releasably mate with the anvil half-section, the cartridge receiving half-section including a pivotable clamping lever, wherein the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining a reinforced access channel formed therein for receiving a respective mounting boss extending laterally from either side of the anvil half-section. Preferably, the access channels are shaped to guide the mounting bosses therethrough to properly assemble the anvil half-section with the cartridge receiving half-section.
• In yet another aspect of the present disclosure, a surgical fastener applying apparatus is disclosed including an anvil half-section; and a cartridge receiving half-section configured and adapted to releasably mate with the anvil half-section, the cartridge receiving half-section including a pivotable clamping lever, wherein the clamping lever includes a body portion having a pair of juxtaposed hinge plates each defining an access channel formed therein for receiving a respective mounting boss extending laterally from either side of the anvil half-section, wherein a portion of the respective access channels are covered by portions of the hinge plate.
• These objects together with other objects of the disclosure, along with various features of novelty which characterize the disclosure, are pointed out with particularity in the claims annexed hereto and forming a part of this disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
• Various embodiments of the presently disclosed surgical fastener applying apparatus will be described herein with reference to the accompanying drawing figures wherein:
• FIG. 1 is a perspective view of one embodiment of a surgical fastener applying apparatus constructed in accordance with the present disclosure;
• FIG. 2 is a perspective view of a disposable staple cartridge assembly for the surgical fastener applying apparatus shown inFIG. 1;
• FIG. 3 is a perspective view, with parts separated, of the disposable staple cartridge assembly ofFIG. 2;
• FIG. 4 is an enlarged left distal perspective view of an embodiment of a staple cartridge loading and lockout mechanism;
• FIG. 5 is an enlarged right side proximal perspective view of the loading and lockout mechanism ofFIG. 4;
• FIG. 6 is a perspective view, with parts separated, showing coupling of the staple cartridge assembly ofFIG. 2 on a cartridge receiving half-section of the surgical fastener applying apparatus ofFIG. 1;
• FIG. 7 is an enlarged perspective bottom view of the loading and lockout mechanism with the staple cartridge assembly ofFIG. 2 operatively coupled thereto;
• FIG. 8 is an enlarged perspective view similar toFIG. 5, with the staple cartridge assembly ofFIG. 2 in place;
• FIG. 9 is an enlarged side perspective view which shows the relative positioning of the loading and lockout mechanism with the staple cartridge assembly ofFIG. 2 installed and with an anvil half-section in place in a clamped condition;
• FIG. 10 is a perspective view which shows the surgical fastener applying apparatus ofFIG. 1 after partial or complete firing and in an unclamped condition with a staple cartridge safety lockout in a locked out position;
• FIG. 11 is an enlarged view of the indicated area of detail ofFIG. 10;
• FIG. 12 is a perspective view with parts separated which shows the structural relationship of the various components of an embodiment of a clamp lever lockout and safety interlock mechanism of the present disclosure;
• FIG. 13 is a top plan view of the surgical fastener applying apparatus with a firing lever in the proximal-most position;
• FIG. 14 is a cross-sectional view taken along section line14-14 ofFIG. 13;
• FIG. 15 is an enlarged view of the indicated area of detail ofFIG. 14;
• FIG. 16 is an enlarged view of the indicated area of detail ofFIG. 14;
• FIG. 17 is a plan view similar toFIG. 13, which shows the firing lever advanced distally a short distance;
• FIG. 18 is a cross-sectional view taken along section line18-18 ofFIG. 17;
• FIG. 19 is an enlarged view of the indicated area of detail ofFIG. 18;
• FIG. 20 is an enlarged view of the indicated area of detail ofFIG. 18;
• FIG. 21 is a perspective view of the cartridge receiving half-section of the surgical fastener applying apparatus ofFIG. 1;
• FIG. 22 is a perspective view of a disposable staple cartridge assembly according to an alternative embodiment of the present disclosure;
• FIG. 23 is a perspective view, with parts separated, of the disposable staple cartridge assembly ofFIG. 22;
• FIG. 24 is a perspective view of the disposable staple cartridge assembly as shown inFIG. 22 with the shipping wedge removed therefrom;
• FIG. 25 is a perspective view of a proximal portion of a cartridge receiving half-section according to an alternative embodiment of the present disclosure;
• FIG. 26 is an enlarged left distal perspective view of a staple cartridge loading and lockout mechanism according to the alternative embodiment ofFIG. 25;
• FIG. 27 is an enlarged right side proximal perspective view of the loading and lockout mechanism ofFIG. 26;
• FIG. 28 is an enlarged bottom side perspective view of the loading and lock out mechanism ofFIG. 26 with a staple cartridge assembly in place thereon;
• FIG. 29 is a partially exploded enlarged bottom side perspective view similar to that of the loading and lock out mechanism shown inFIG. 28;
• FIG. 30 is an enlarged top side perspective view similar to the loading and lock out mechanism ofFIG. 27;
• FIG. 31 is an enlarged side perspective view which shows the relative positioning of the loading and lockout mechanism with an anvil half-section in place thereon;
• FIG. 32 is a perspective view of the surgical fastener applying apparatus ofFIGS. 21-40, in an unclamped condition, with a cartridge receiving half-section clamp lever in an open position;
• FIG. 33 is a perspective view, with parts separated, which shows the structural relationship of the various components of a clamp lever lockout and safety interlock mechanism;
• FIG. 34 is a cross-sectional view of the surgical fastener applying apparatus ofFIGS. 21-40, in a pre-fired condition, taken along the longitudinal center line thereof;
• FIG. 35 is an enlarged view of the indicated area of detail ofFIG. 34;
• FIG. 36 is an enlarged view of the indicated area of detail ofFIG. 34;
• FIG. 37 is a cross-sectional view of the surgical fastener applying apparatus ofFIGS. 21-40, in a post-fired condition, taken along the longitudinal center line thereof;
• FIG. 38 is an enlarged view of the indicated area of detail ofFIG. 37;
• FIG. 39 is an enlarged view of the indicated area of detail ofFIG. 37;
• FIG. 40 is a perspective view of the cartridge receiving half-section of the surgical fastener applying apparatus ofFIGS. 21-40 after partial or complete firing with a staple cartridge safety lockout in a locked out position;
• FIG. 41 is a schematic perspective view of a surgical fastener applying apparatus according to another alternative embodiment of the present disclosure, with a cartridge receiving half-section clamp lever shown in an open position;
• FIG. 42 is an enlarged schematic perspective view of the mounting bracket of the cartridge receiving half-section clamp lever shown inFIG. 41;
• FIG. 43 is an enlarged schematic perspective view of an alternate embodiment of a mounting bracket for the cartridge receiving half-section clamp lever shown inFIG. 41 with the cartridge receiving half-section clamp lever shown in an open condition;
• FIG. 44 is an enlarged perspective view of the mounting bracket ofFIG. 43 with the cartridge receiving half-section clamp lever shown in a closed condition;
• FIG. 45 is a cross-sectional view of the mounting bracket ofFIG. 43 taken along section line45-45;
• FIG. 46 is a cross-sectional view of the mounting bracket ofFIG. 43 taken along section line46-46;
• FIG. 47 is an enlarged schematic perspective view of the mounting bracket ofFIG. 43 with a handle cover covering each of the cartridge and the anvil half-section clamp levers;
• FIG. 48 is an enlarged perspective view of the underneath of a proximal end of an anvil frame side with the anvil half-section clamp lever in the closed position;
• FIG. 49 is a perspective view of the proximal end of the surgical fastener applying apparatus depicting the engagement of the proximal ends of the cartridge and anvil half-section clamp levers;
• FIG. 50 is a perspective view of still another embodiment of a surgical fastener applying apparatus constructed in accordance with the present disclosure;
• FIG. 51 is a perspective view of the surgical fastener applying apparatus ofFIG. 50 opened from a cartridge receiving half-section side with a cartridge receiving half-section clamp lever opened;
• FIG. 52 is an enlarged perspective view of the indicated area ofFIG. 51;
• FIG. 53 is an enlarged perspective view of a distal end of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 54 is a distal side perspective view of the surgical fastener applying apparatus ofFIG. 50 with the contoured handles removed therefrom;
• FIG. 55 is a rear perspective view of the surgical fastener applying apparatus ofFIG. 54;
• FIG. 56 is a perspective view, with parts separated, of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 57 is a perspective view, with parts separated, of the anvil half-section side of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 58 is an enlarged perspective view of an eccentric cam in accordance with the present disclosure;
• FIG. 58A is a side elevational view of the eccentric cam as shown inFIG. 58;
• FIG. 58B is a rear elevational view of the eccentric cam as shown inFIG. 58;
• FIG. 59 is a perspective view of the anvil half-section side of the surgical fastener applying apparatus ofFIG. 50, as seen from the bottom;
• FIG. 60 is an enlarged view of the indicated area ofFIG. 59;
• FIG. 61 is an enlarged view of the indicated area ofFIG. 59;
• FIG. 62 is a side elevational view of the anvil half-section detailing the eccentric cam ofFIG. 58;
• FIG. 63 is a cross-sectional view, taken along the longitudinal axis, of the anvil half-section as seen inFIG. 62;
• FIG. 64 is a side elevational view of the anvil and cartridge receiving half-sections coupled to one another detailing the operation of the eccentric cam ofFIG. 58;
• FIG. 65 is a side-elevational view of the anvil and cartridge receiving half-sections coupled to one another further detailing the operation of the eccentric cam ofFIG. 58;
• FIG. 66 is a top perspective view of the cartridge receiving half-section shown with the clamp lever in the open position;
• FIG. 67 is a perspective view, with parts separated, of the disposable staple cartridge assembly of the surgical stapler applying apparatus ofFIG. 50;
• FIG. 68 is a perspective view, as seen from the bottom, of a safety lock out of an embodiment of the present disclosure;
• FIG. 69 is a perspective view of a firing slide, as seen from the bottom, of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 70 is a perspective view, with parts separated, of the firing slide ofFIG. 69;
• FIG. 71 is a perspective view of a proximal end of the center bar of the firing slide ofFIG. 69;
• FIG. 72 is a top perspective view of a proximal end of the firing slide ofFIG. 69;
• FIG. 73 is a perspective view of a slide block of the firing slide ofFIG. 69;
• FIG. 74 is a bottom perspective view of a firing lever of the firing slide ofFIG. 69;
• FIG. 75 is a cross-sectional view of the proximal end of the firing slide ofFIG. 69;
• FIG. 76 is a perspective view of the lock out mechanism of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 77 is a perspective view, with parts separated, of the cartridge receiving half-section frame of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 78 is a bottom perspective view of the cartridge receiving half-section frame ofFIG. 77;
• FIG. 79 is a perspective view of a cartridge receiving half-section side of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 80 is an enlarged view of the indicated area of detail ofFIG. 79;
• FIG. 81 is an enlarged view of the indicated area of detail ofFIG. 79;
• FIG. 82 is a perspective view of a handle cover for the cartridge lever of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 83 is a perspective view of a cartridge receiving half-section clamp lever of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 84 is another perspective view of the cartridge receiving half-section clamp lever ofFIG. 50;
• FIG. 85 is a perspective view of a cartridge lever release member;
• FIG. 86 is a perspective view of a leaf spring mounting plug of the surgical fastener applying apparatus ofFIG. 50;
• FIG. 87 is a cross-sectional view of the surgical fastener applying apparatus, taken along the longitudinal axis, depicting the coupling of the cartridge receiving half-section to the anvil half-section;
• FIG. 88 is an enlarged view of the indicated area of detail ofFIG. 87;
• FIG. 89 is an enlarged view of the indicated area of detail ofFIG. 87;
• FIG. 90 is an enlarged view of the indicated area of detail ofFIG. 87;
• FIG. 91 is an enlarged side elevational view of the proximal end of anvil half-section being coupled to the cartridge receiving half-section;
• FIG. 92 is a cross-sectional view, taken along the longitudinal axis, of the surgical fastener applying apparatus ofFIG. 50, in a closed pre-firing condition;
• FIG. 93 is an enlarged view of the indicated area of detail ofFIG. 92;
• FIG. 94 is an enlarged view of the indicated area of detail ofFIG. 92;
• FIG. 95 is a top plan view of the surgical fastener applying apparatus ofFIG. 50, in a post-firing condition;
• FIG. 96 is a cross-sectional view, taken along the longitudinal axis, of the surgical fastening applying apparatus ofFIG. 50, in the post-firing condition;
• FIG. 97 is an enlarged view of the indicated area of detail ofFIG. 96;
• FIG. 98 is an enlarged view of the indicated area of detail ofFIG. 96;
• FIG. 99 is a perspective view of the surgical fastener applying apparatus ofFIG. 50, in an open post-firing condition;
• FIG. 100 is an enlarged view of the indicated area of detail ofFIG. 99;
• FIG. 101 is a cross-sectional view of the surgical fastener applying apparatus ofFIG. 50, in an open post-firing condition, taken along the longitudinal axis; and
• FIG. 102 is an enlarged view of the individual area of detail ofFIG. 101.
DETAILED DESCRIPTION
• Embodiments of the presently disclosed devices are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “distal” or “leading” refers to that portion of the device that is farther from the user, while the term “proximal” or “trailing” refers to that portion of the device that is closer to the user.
• Preferred embodiments of surgical fastener applying apparatus in accordance with the present disclosure will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical structural elements. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term “proximal” refers to the end of the apparatus which is closer to the user and the term “distal” refers to the end of the apparatus which is further away from the user.
• Referring initially toFIGS. 1-22, an illustrative embodiment of the presently disclosed surgical fastener applying apparatus is illustrated therein and designated generally assurgical stapler10.Surgical stapler10 is particularly adapted to apply a plurality of adjacent rows of staples to body tissue clamped in between the instrument's two principle sections, a cartridge receiving half-section12 and an anvil half-section14. Typical applications of the presently disclosed surgical fastener apparatus are, for example, creating a hemostatic seal in general, thoracic, and urologic surgery for resection, transection and creation of anastomoses. Specific tissue structures in which the instrument may be used are, for example, the stomach, the large and small bowels, lungs and the esophagus.
• Turning now toFIGS. 2 and 3,surgical stapler10 is designed for use with a disposablestaple cartridge assembly16, such as, for example, a single use disposable loading unit (“SULU”).Cartridge assembly16 includes acartridge body18, a plurality ofstaple pushers20, abottom cover22, aknife24 having an angled sharpenedleading edge24a, a plurality ofstaples26, a pivotably mountedsafety lockout28 and aremovable shipping wedge30. As with known staple cartridge designs,cartridge body18 has a plurality of rows ofstaple retaining slots32 formed therein.Surgical stapler10 may be manufactured and assembled in different sizes to receive differentsize cartridge assemblies16. For example,surgical stapler10 can be made in different sizes to acceptcartridge assemblies16 having staple line lengths of approximately 60 mm, 80 mm, and 100 mm.
• Alternatively,cartridge assemblies16 may be adapted such that one commonsurgical stapler10 will accept multiple different staple count cartridge assemblies. For example,cartridge assemblies16 may be configured such that each different staple count cartridge assembly shares a commonsize cartridge body18 to facilitate mounting onsurgical stapler10.
• In the illustrated embodiment, there are two staggered rows ofslots32 formed on either side of a linear slottedtrack34 which guidesknife24 during its longitudinal movement. Asingle staple26 is positioned in each ofslots32. The staple rows preferably extend a distance distally beyond the distal end ofknife track34 to facilitate staple formation beyond the stroke length ofknife24.
• Staple pushers20 are aligned one each withslots32 such that a singlestaple pusher member20 is positioned under arespective staple26 which is retained withinslot32.Staple pushers20 are formed such that they are attached to each other in groups of two offset oriented pusher pairs and have an actuating surface (not shown) connecting each pair ofpusher members20.
• Staple pushers20 are arranged in two series, one on each side of slottedtrack34, such that the actuating surfaces of each series ofstaple pushers20 forms a line centered between the staggered rows ofstaples26. The actuating surfaces act as cam followers and interact with a pair of staggered camming surfaces36,38 extending from a generally U-shaped cam bar40 (seeFIGS. 4 and 5) to expel the pairs ofstaples26 on each side ofknife track34. As illustrated, camming surfaces36,38 form a single angle relative to horizontal. In certain applications, for example, with staples having an unformed leg height of about 4.5 mm, camming surfaces36,38 may be formed of a plurality of angles to facilitate optimal staple deformation with a given firing force, ascam bar40 is moved distally. This sequence is repeated until the distal movement ofcam bar40 is either stopped intentionally by the user to form less than all ofstaples26 or until all ofstaples26 are expelled fromcartridge assembly16.
• Bottom cover22 partially encloses the bottom of a channel formed by the upper surface of the channel bottom wall and the side walls ofcartridge body18. Alongitudinal ridge22ais formed on an upper surface ofbottom cover22 and serves as a bearing surface forknife bearing channel42, which is secured to the bottom edge ofknife24, as it travels inknife track34. A pair of slots are formed, one on either side oflongitudinal ridge22a, the outer limit of each slot being defined by the outer side wall ofcartridge body18 on a respective side ofridge22a. These slots facilitate reciprocating longitudinal movement of the extensions of camming surfaces36,38 of generallyU-shaped cam bar40. Knifebearing channel member42 which is preferably wider thanknife track34, is secured to the bottom surface of theknife24 such that knife bearingchannel member42 rides betweenknife track34 andlongitudinal ridge22aofbottom cover22. In this manner,knife24 is prevented from undergoing substantial vertical movement during longitudinal translation inknife track34.
• Safety lockout28 is pivotably disposed on the upper proximal end ofcartridge body18 and is movable from a locked orientation to an unlocked orientation. Preferably,safety lockout28 is biased away from the unlocked orientation towards an orientation substantially perpendicular to the longitudinal axis ofcartridge body18. Any suitable bias member may be utilized such as, for example, springs44,46. To overcome the bias towards the perpendicular orientation,safety lockout28 includes a transversehorizontal surface28a, preferably a projection (seeFIG. 15) formed on the underside thereof which engages a member, preferably a projection or ahook24bformed on the upper edge surface ofknife24. This cooperative engagement serves to retainsafety lockout28 in the locked orientation whereinsafety lockout28 coversknife24.
• Whensurgical stapler10 has been unclamped, as will be described in greater detail further herein, after either partial or complete firing ofsurgical stapler10,safety lockout28 is biased to the perpendicular orientation (seeFIGS. 10 and 11), extending upwardly away from cartridge receiving half-section12. In this manner,safety lockout28 preventssurgical stapler10 from being re-clamped until the partial or completely firedcartridge assembly16 is removed and replaced with anew cartridge assembly16.Safety lockout28 also provides a cut-out grasping surface28bwith whichcartridge assembly16 may readily be removed fromsurgical stapler10.
• As previously noted,shipping wedge30 is removably attachable tocartridge body18. When installed oncartridge assembly16,shipping wedge30 covers the entire surface area ofstaple rows26 andknife track34. Additionally,shipping wedge30 includes anabutment30aextending upwardly and proximally from an upper proximal surface thereof.Abutment30ain cooperation withsafety lockout28 covers sharpeneddistal edge24aofknife24. This feature preventsknife24 from being exposed to the user during handling ofcartridge assembly16. Additionally,abutment30aprevents premature pivotal movement ofsafety lockout28 from the locked orientation. Thus, even ifcartridge assembly16 is properly loaded onsurgical stapler10,staples26 cannot be fired until shippingwedge30 is first removed.
• Shippingwedge30 also includes a post30bextending downwardly from the underside thereof near the proximal end. Post30bfits into a complementary shapedopening18cformed incartridge body18 at the proximal end ofknife track34. Withshipping wedge30 in place, post30bblocks potential distal movement ofknife26. In an alternative embodiment,cartridge assemblies16 may also be provided without a knife in applications where it is desirable to perform stapling without transection. In such an embodiment,knife26 is replaced with a blank element to substitute for the knife to interact withsafety lockout28.
• Cartridge body18 is provided with several shaped surfaces to facilitate mounting and alignment ofcartridge assembly16 with respect to cartridge receiving half-section12 ofsurgical stapler10. Such alignment facilitating surfaces may be formed at any suitable location on the various components ofcartridge body18 to correspond with complementary surfaces on cartridge receiving half-section12. In the illustrated embodiment, locating/alignment feature surfaces18aare formed extending downwardly on either side ofcartridge assembly16 near the proximal end thereof and molded surfaces18bare formed on either side ofcartridge body18 near the distal end thereof. Whencartridge assembly16 is properly installed onsurgical stapler10, surfaces18aseat in a pair ofnotches48,50 (seeFIGS. 4, 5, 6 and 8) formed in cartridge receiving half-section12.
• Referring toFIGS. 4-9, a loading andlockout mechanism50 forcartridge assembly16 will now be described in detail. In these figures, achannel frame12a(seeFIG. 12) of cartridge receiving half-section12 is not shown so that loading andlockout mechanism50 can be illustrated more clearly. Loading andlockout mechanism50 facilitates loading ofcartridge assembly16 and prevents firing ofsurgical stapler10 untilcartridge assembly16 is properly loaded or assembled on cartridge receiving half-section12 andsurgical stapler10 is properly clamped shut. Loading andlockout mechanism50 includes arocker52 which is pivotably mounted tochannel frame12a(seeFIG. 12) of cartridge receiving half-section12 by way of transversely extendingpost portions52aseating in openings formed through the sidewalls ofchannel frame12a.Post portions52aare provided with angled downwardly oriented surfaces to facilitate assembly ofrocker52 withchannel frame12a.Rocker52 is preferably a molded plastic component and is provided with three slots, namely open bottomedslots52b,52cto permit longitudinal movement ofcam bar40 and aclosed slot52dto permit passage of a center bar54 (seeFIG. 4) therethrough.
• As best shown inFIGS. 5 and 7,rocker52 is further provided with a downwardly extending blockingsurface52ewhich is in vertical alignment with anopening40aformed through the bottom surface ofcam bar channel40 whencam bar channel40 is in its proximal-most position.Rocker52 is biased, by way of aspring56 which is disposed between downwardly extendingleg52fand anend wall58aof abeam member58, toward a locked-out vertical or upstanding position wherein blockingsurface52eextends through opening40a. In this manner,cam bar40 is prevented from distal longitudinal movement. In versions ofsurgical stapler10 usingshorter cartridge assemblies16,beam member58 may be eliminated.
• Upon loading ofcartridge assembly16 on cartridge receiving half-section12, as shown inFIG. 8, the spring bias ofspring56 maintainsrocker52 in the locked-out position. It is only when anvil half-section14 is joined with cartridge receiving half-section12 and the half-sections clamped together, as seen inFIG. 9, thereby causing downwardly extendingleg portions60aformed on either side of anvil half-section channel member60 to bias againstcartridge assembly16, thatrocker52 is urged to rotate by the camming action of proximal end surface ofcartridge assembly16 against thedistal end surface51 ofrocker52. In this manner, blockingsurface52eis moved out of (i.e., pivoted out of) longitudinal alignment with opening40aofcam bar channel40 thereby permitting a distal longitudinal movement ofcam bar channel40.
• Referring toFIGS. 10 and 11, oncesurgical stapler10 has been at least partially fired, if the instrument is opened,safety lockout28 ofcartridge assembly16 automatically moves to the perpendicular orientation due to the spring bias mounting thereof. Withsafety lockout28 in this orientation,surgical stapler10 cannot be re-clamped. Thus, if the user desires to apply further staples, partially or completely firedcartridge assembly16 must first be removed and replaced with anon-fired cartridge assembly16.
• As will be described in greater detail below and as seen inFIGS. 12 and 21,surgical stapler10 is provided with a pivotably mounted firinglever65. Pivotally mounted firinglever65 provides the user with the ability to firesurgical stapler10 from either the left or right side.
• Referring toFIG. 12,surgical stapler10 is provided with a clampinglever62 pivotably mounted to cartridge receiving half-section12. An ergonomic contoured handle66 (seeFIG. 10) is secured to clampinglever62 to provide the user with a convenient gripping handle. To further enhance the gripping ofsurgical stapler10 by the user, a friction enhancing insert70 (seeFIG. 10) is secured tohandles66 and68.Insert70 may be formed of any suitable friction enhancing material, for example, rubber. As seen inFIG. 10, anvil half-section14 is provided with an ergonomic contouredhandle68 secured to anvil half-section channel member60 to provide the user with a convenient gripping handle. Half-sections12 and14 are preferably configured and dimensioned to provide the user with the ability to reach around both halves and comfortably closesurgical stapler10 with a one-handed operation in order to approximate the half-sections and clamp the captured tissue.
• Referring also toFIGS. 14-16 and 18-20, a clamp latch andsafety interlock mechanism70 is provided at the proximal end ofsurgical stapler10. Clamp latch andsafety interlock mechanism70 serves to retainclamp lever62 in a clamped orientation as well as to provide a safety interlock which prevents opening ofclamp lever62 once firinglever65 is moved distally. Cartridge receiving half-section12 is provided with a clamp latch andsafety interlock mechanism70 which works to latchclamp lever62 in a clamped configuration upon squeezingclamp lever62 to the closed position. While aclamp lever62 is shown and described as being pivotably mounted to cartridge receiving half-section12, it is envisioned that a clamp lever can be pivotably mounted to anvil half-section14 or a clamp lever can be pivotably mounted to each of cartridge receiving half-section12 and anvil half-section14. Accordingly, the following description of the various components which make up the assembly will be directed to that for the cartridge receiving half-section12 as shown inFIG. 12.
• Clamp latch andsafety interlock mechanism70 includes a distalclamp lever latch74 and aproximal interlock latch76 which is spring biased distally toward a latched position. As seen inFIG. 16, whensurgical stapler10 is in the clamped configuration with firinglever65 in the proximal-most position, afiring slide block78 biases latch76 proximally to overcome the distal spring bias to positionledge76aoflatch76 out of lateral alignment withproximal ledge74aformed onlatch74 thereby positioning and maintaininglatch76 in an unlatched position. In this position, the user may unclampclamp lever62 by squeezing spring biasedfinger pad portions80a,80bof latch handle release member80 (seeFIG. 12) which urgeslatch74 proximally such that distal ledge74bis moved out of lateral alignment with the blocking structure formed on cartridge receiving half-section12a(not shown).
• Once firinglever65 is moved distally to begin the firing sequence ofsurgical stapler10, as shown inFIGS. 17, 18 and 20,slide block78 is also moved distally thereby removing the biasing force which overcame the distal spring bias oflatch76. Thus,ledge76amoves into lateral alignment withledge74aoflatch74 thereby preventingclamp lever62 from being opened until firinglever65 is once again moved to the proximal-most position. The instrument is thereby prevented from opening during the firing stroke.
• Upon initial distal movement, firinglever65 becomes locked-out from pivotal movement by way of firinglever65 being cammed upwardly to overcome an upward spring bias, as shown in the operationally progressive views ofFIGS. 16 and 20. In particular, as best shown inFIG. 21, recessednotches65a,65bare formed as keyways which engage a key78aformed onslide block78, respectively, depending upon which side of firinglever65 is employed to actuate firing. Firinglever65 can be returned to the proximal-most position at any time during the firing stroke. Firinglever65 must be returned to the proximal-most position before the lever can be released and the instrument unclamped. As described previously, if the instrument is opened after firing, either partially or completely,safety lockout28 oncartridge assembly16 is configured to prevent the user from re-clamping the instrument.
• Turning now toFIGS. 22-41, an alternative embodiment of a disposable staple cartridge assembly is generally shown as116. As seen inFIGS. 22-24,staple cartridge assembly116 includes acartridge body118, a plurality ofstaple pushers120, abottom cover122, aknife124 having an angled sharpenedleading edge124aand an atraumaticforward tip124c, a plurality ofstaples126, a pivotably mountedsafety lockout128 and aremovable shipping wedge130. As with known staple cartridge designs,cartridge body118 has a plurality of rows ofstaple retaining slots132 formed therein.
• Alternatively,cartridge assembly116 may be adapted such that one common surgical stapler100 (seeFIG. 33) will accept multiple different staplecount cartridge assemblies116. For example,cartridge assembly116 may be configured such that each different staplecount cartridge assembly116 shares a commonsize cartridge body118 to facilitate mounting onsurgical stapler100.
• In the present illustrated embodiment, there are two staggered rows ofslots132 formed on either side of a linear slottedtrack134 which guidesknife124 during its longitudinal movement. Asingle staple126 is positioned in each ofslots132. The staple rows preferably extend a distance distally beyond the distal end ofknife track134 to facilitate staple formation beyond the stroke length ofknife124.Staple pushers120 are formed such that they are attached to each other in groups of two offset oriented pusher pairs.
• Staple pushers120 are arranged in two series, one on each side of slottedtrack134, such that the actuating surfaces of each series ofstaple pushers120 forms a line centered between the staggered rows ofstaples126. The actuating surfaces act as cam followers and interact with a pair of staggered camming surfaces136 and138 extending from a pair of cam bars140 (seeFIGS. 25-27) to expel the pairs ofstaples126 on each side ofknife track134. As illustrated, camming surfaces136 and138 form a single angle relative to horizontal as eachcam bar140 is moved distally. This sequence is repeated until the distal movement of eachcam bar140 is either stopped intentionally by the user to form less than all ofstaples126 or until all ofstaples126 are expelled fromcartridge assembly116.
• Bottom cover122 partially encloses the bottom of a channel formed by the upper surface of the channel bottom wall and the side walls ofcartridge body118. Alongitudinal ridge122ais formed on an upper surface ofbottom cover122 and serves as a bearing surface forknife bearing channel142, which is secured to the bottom edge ofknife124, asknife124 travels inknife track134. A pair of slots is formed one on either side oflongitudinal ridge122a, the outer limit of each slot being defined by the outer side wall ofcartridge body118 on a respective side ofridge122a. These slots facilitate reciprocating longitudinal movement of the extensions of camming surfaces136,138 of generallyU-shaped cam bar140. Knifebearing channel member142 which is preferably wider thanknife track134, is secured to the bottom surface ofknife124 such that knife bearingchannel member142 rides betweenknife track134 andlongitudinal ridge122aofbottom cover122. In this manner,knife124 is prevented from undergoing substantial vertical movement during longitudinal translation inknife track134.
• Safety lockout128 is pivotably disposed on the upper proximal end ofcartridge body118 and is movable from a locked orientation to an unlocked orientation. Preferably,safety lockout128 is biased away from the locked orientation towards an orientation substantially perpendicular to the longitudinal axis ofcartridge body118. Any suitable bias member may be utilized such as, for example,spring144. To overcome the bias towards the perpendicular orientation,safety lockout128 includes a transversehorizontal surface128a(seeFIG. 35) formed on the underside thereof which engages a hook124bformed on the upper edge surface ofknife124. This cooperative engagement serves to retainsafety lockout128 in the locked orientation whensafety lockout128 coversknife124.
• Whensurgical stapler100 has been unclamped, as will be described in greater detail further herein, after either partial or complete firing,safety lockout128 is biased to the perpendicular orientation (seeFIG. 40), extending upwardly away from cartridge receiving half-section112. In this manner,safety lockout128 preventssurgical stapler100 from being re-clamped until the partial or completely firedcartridge assembly116 is removed and replaced with anew cartridge assembly116.Safety lockout128 also provides a cut-out grasping surface128bwith whichcartridge assembly116 may readily be removed fromsurgical stapler100.
• As previously noted,shipping wedge130 is removably attachable tocartridge body118. When installed oncartridge assembly116,shipping wedge130 covers the entire surface area ofstaple rows126 andknife track134.Shipping wedge130 includes a post130bextending downwardly from the underside thereof near the proximal end thereof. Post130bfits into a complementary shapedopening118cformed incartridge body118 at the proximal end ofknife track134. Withshipping wedge130 in place, post130bblocks potential distal movement ofknife126. Post130bmaintainsknife134 retained withinsafety lockout128 thereby ensuring that the sharpeneddistal edge124aofknife124 is covered. Once again,cartridge assembly116 may be provided without a knife in applications where it is desirable to perform stapling without transection. In such an embodiment,knife126 is replaced with a blank element to substitute for the knife to interact withsafety lockout128.
• Cartridge body118 includes a series of finger grips127 formed along the upper sides near a proximal end thereof. Finger grips127 assist the user in grippingcartridge assembly116 for both installation and removal ofcartridge assembly116 from cartridge receiving half-section112.Cartridge body118 also includes a pair ofresilient friction fingers129 disposed on either side near a proximal end thereof.Friction fingers129 are configured and adapted to project outwardly fromcartridge body118 and to frictionally engage the inner surface of cartridge receiving half-section112. In this manner, thefriction fingers129 preventcartridge assembly116 from falling out of the cartridge receiving half-section112.
• Referring toFIGS. 25-31, a loading andlockout mechanism150 forcartridge assembly116 will now be described in detail. Loading andlockout mechanism150 facilitates loading ofcartridge assembly116 and prevents firing ofsurgical stapler100 untilcartridge assembly116 is properly loaded on cartridge receiving half-section112 andsurgical stapler100 is properly clamped shut. Loading andlockout mechanism150 includes arocker152 which is pivotably mounted to achannel frame112a(seeFIG. 31) of cartridge receiving half-section112 by way of transversely extendingpost portions152aseating in openings formed through the sidewalls ofchannel frame112a.Post portions152aare provided with angled downwardly oriented surfaces to facilitate assembly ofrocker152 withchannel frame112a.Rocker152 is preferably a molded plastic component and is provided with three slots, namely open bottomedslots152b,152cto permit longitudinal movement ofcam bar140 and aclosed slot152dto permit passage of a center bar154 (seeFIG. 27) therethrough.
• As best shown inFIG. 28,rocker152 is further provided with a downwardly extendingblocking surface152ewhich is in vertical alignment with anopening140aformed through the bottom surface of eachcam bar140 when eachcam bar140 is in its proximal-most position.Rocker152 is biased, by way of aspring156 which is disposed on transversely extendingpost portion152aand between aridge152fformed on a side of therocker152 and upper surface of the cartridge half section112 (seeFIG. 26), toward a locked-out position wherein blockingsurface152eextends through opening140a. In this manner, eachcam bar140 is prevented from distal longitudinal movement.
• Upon loadingcartridge assembly116 on cartridge receiving half-section112 as shown inFIGS. 26-31, the spring bias maintainsrocker152 in the locked-out position. It is only when anvil half-section114 is joined with cartridge receiving half-section112 and the half-sections clamped together, thereby causing downwardly extendingleg portions160aformed on either side of anvil half-section channel member160 to bias againstcartridge assembly116, thatrocker152 is urged to rotate by the camming action of proximal end surface ofcartridge assembly116 against the distal end surface ofrocker152. In this manner, blockingsurface152eis moved out of (i.e., pivoted out of) longitudinal alignment with opening140aof eachcam bar140 thereby permitting a distal longitudinal movement ofcam bar140.
• Similar to the embodiment shown inFIGS. 2-21, oncesurgical stapler100 has been at least partially fired, if the instrument is opened,safety lockout128 ofcartridge assembly116 automatically moves to the perpendicular orientation due to the spring bias mounting thereof. Withsafety lockout28 in this orientation,surgical stapler100 cannot be re-clamped. Thus, if the user desires to apply further staples, fired or partially firedcartridge assembly116 must first be removed and replaced with anon-fired cartridge assembly116.
• Referring toFIG. 32,surgical stapler100 is provided with clampinglever162 and a pivotably mountedfiring lever165. Like firinglever65 of the first embodiment, firinglever165 of the present embodiment provides the user with the ability to firesurgical stapler100 from either the left or right side.
• Clampinglever162 is pivotably mounted to cartridge receiving half-section112. An ergonomic contouredhandle166 is secured to clampinglever162 to provide the user with a convenient gripping handle. To further enhance the gripping ofsurgical stapler100 by the user, afriction enhancing insert170 is secured to handle166.
• Unlike the embodiment ofFIGS. 2-21, thesurgical stapler100 ofFIGS. 22-41 does not include a clamp latch safety interlock mechanism. In this manner, the user can open thesurgical stapler100 after a complete or partial firing of thecartridge assembly116. Referring now toFIGS. 33-39, a clamp latch mechanism, according to the alternative embodiment, is provided at the proximal end ofsurgical stapler100 which serves to retainclamp lever162 in a clamped orientation. Cartridge receiving half-section112 is provided with a clamp latch mechanism which works to latchclamp lever162 in a clamped configuration upon squeezingclamp lever162 to the closed position. Once again, while asingle clamp lever162 is shown and described as being pivotably mounted to cartridge receiving half-section112, it is envisioned that a clamp lever can be pivotably mounted to anvil half-section114 or a clamp lever can be pivotably mounted to each of cartridge receiving half-section112 and anvil half-section114. Accordingly, the following description of the various components which make up the clamp latch mechanism will be directed to that for the cartridge receiving half-section112.
• As shown inFIG. 33, the clamp latch mechanism includes a distalclamp lever latch174 formed at a proximal end of the cartridge receiving half-section112 and latchhandle release member180 operatively coupled to a proximal end ofclamp lever162. Latchhandle release member180 is spring biased proximally toward a latched position and is provided with a catch182 (seeFIG. 36) for engagingclamp lever latch174. In order to releaseclamp lever162, the user pressesrelease member180 in the distal direction, thereby disengagingcatch182 fromlatch174.
• In order to prevent inadvertent opening of theclamp lever162,release member180 is provided with aprojection184 extending downwardly from a proximal end thereof, whichprojection184 is seated within aguard186 formed at the proximal end of thelever162. It is envisioned that theguard186 can be integral with thehandles166 and168 and made of a resilient material to enable the user to more easily move theguard186 and thereby depress therelease member180.
• Further, as seen inFIG. 33,surgical stapler100 is provided with a firinglever slide block188.Slide block188 includes ahub190 projecting therefrom and configured and adapted to be received in apivot hole192 formed in firinglever165.Slide block188 is configured and adapted to be slidably received in the cartridge receiving half-section112. In use, firinglever165 is pivotable abouthub190 thereby providing the user with the ability to manipulate firinglever165 from either side of thesurgical stapler100.
• As seen inFIGS. 32-35, 37, 38 and 40,surgical stapler100 is provided with a staplegap adjustment mechanism200 which enables eachstapler100 to be manufactured and assembled with a very precise staple gap between the cartridge assembly and the anvil structure of the surgical stapler. The staplegap adjustment mechanism200 shown inFIGS. 32-35, 37, 38 and 40 is the subject of commonly owned and co-pending International Application PCT/US02/31963 filed on Oct. 4, 2002 which claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/327,369, filed on Oct. 5, 2001, entitled “Surgical Stapling Apparatus”, the entire contents of which are incorporated herein by reference. According to the present embodiment,gap adjustment mechanism200 includes a pair ofupstanding hinge plates202 formed along the sides of the cartridge receiving half-section112, and aneccentric cam206. Eachhinge plate202 is provided with a coaxial throughhole204 which is configured and adapted to receive theeccentric cam206 therein. In use, aseccentric cam206 is rotated, a central portion, for example,474 inFIG. 58A, ofeccentric cam206 presses against portions of anvil half-section114 while end portions, for example,472 and476 ofFIG. 58A, ofeccentric cam206 press against a portion of cartridge receiving half-section122 until the desired staple gap between the anvil half-section114 and thecartridge half section112 is achieved. Once it is achieved,eccentric cam206 is fixedly secured in the throughholes204. This feature will be discussed in greater detail below.
• Turning now toFIGS. 41-49, an alternative embodiment ofsurgical stapler100 is depicted in whichsurgical stapler100 includes a cartridge receiving half-section clamp lever112ahaving a pair of juxtaposed mountingbrackets300 formed at a distal end thereof. Each mountingbracket300 is provided with anaccess slot302 formed therein. Preferably, eachaccess slot302 is oriented or accessible substantially vertically (i.e., oriented substantially orthogonally with respect to a longitudinal axis of surgical stapler100) when cartridge receiving half-section clamp lever112ais in an open position (as seen inFIGS. 42 and 43). More preferably, each access slot is oriented to face mountingpins304 whenclamp lever112ais in the open position. Eachaccess slot302 is configured and adapted to slidably receive a terminal end of a mountingpin304 which extends and projects from the lateral surfaces of anvil receiving half-section114 a distance sufficient to engage eachaccess slot302 and has a cross-sectional dimension enabling it to be received within each access slot302 (seeFIGS. 45 and 46).
• It is envisioned that each mountingbracket300 can be provided with a reinforcing member306 (seeFIGS. 42-44) extending across eachaccess slot302 for strengthening, supporting and reinforcing the distal end of eachaccess slot302. Preferably, each reinforcingmember306 can be formed by stamping out an elongated slot in each mountingbracket300 and folding or doubling over a distal end of mountingbracket300, over or across the elongated slot, to thereby provide an open distal end of eachaccess slot302 and to create reinforcingmember306. Alternatively, each reinforcingmember306 can be formed by terminating each mountingbracket300 at a point along theaccess slot302 and fixedly attaching a cross-bar acrossaccess slot302, or by any other suitable method known by those skilled in the art. Eachaccess slot302 extends into and interconnects with acam slot308 also formed in each mountingbracket300.
• Mounting of anvil half-section114 to cartridge receiving half-section112 will now be described in connection withFIGS. 43, 44 and 47. With cartridge receiving half-section clamp lever112ain an open position, anvil half-section114 is united with cartridge receiving half-section112 by aligning each opposed mountingpin304 with arespective access slot302 and advancing (i.e., moved forward, dropped-in, etc.) cartridge receiving and anvil half-section112,114 toward one another until mountingpins304 are completely seated withinaccess slots302.Access slots302 ensure that half-sections112,114 are juxtaposed and in proper alignment with one another. Once mountingpin304 is properly and completely seated withinaccess slot302, cartridge receiving half-section clamp lever112ais manipulated (i.e., pivoted) to a closed position (as seen inFIGS. 44 and 47) whereby each end of mountingpin304 is advanced throughcam slots308 thereby closingsurgical stapler100 as a result of the camming action taking place therebetween.
• Preferably, when the anvil receiving half-section114 is oriented in the horizontal plane and theclamp lever112ais in the first position, the opening to eachaccess slot302 can be vertically accessed. It is envisioned that eachaccess channel302 is generally orthogonal to the cartridge receiving half-section112. As seen inFIG. 42, it is further envisioned that eachaccess channel302 faces angularly relative to the cartridge receiving half-section112. It is contemplated that eachaccess slot302 can be generally L-shaped.
• As seen throughout the figures the distal end of the anvil half-sections preferably taper downwardly in height from a proximal end portion toward the distal end portion thereof. By way of example only, the proximal end portion of the anvil half-sections preferably have a height of about 11.7 mm while the distal end portions of the anvil half-sections preferably have a height of about 10.2 mm, when the anvil half-sections have a length of about 100 mm.
• In order to reinforce and strengthen the distal end of the anvil half-sections and to reduce a tendency of the distal end of the anvil half sections to deflect as a result of the stapling forces acting thereon, it is envisioned that at least one vertically oriented longitudinally running reinforcing strip (not shown in the present embodiment) is provided therewithin. The reinforcing strip is preferably made of a substantially rigid non-flexible material, such as, for example, stainless steel. It is contemplated that the reinforcing strip can be either welded, crimped and/or snapped or otherwise friction fit into place. It is further envisioned that the distal end of the anvil half-sections are provided with at least one transverse and/or longitudinal reinforcing wall (not shown) in order to reduce the tendency of the distal end of the anvil half-sections from deforming due to torsional forces.
• Turning now toFIGS. 48 and 49, the proximal end of cartridge receiving half-section112 is provided with a pair of juxtaposedpivot plates310 extending upwardly therefrom. Eachpivot plate310 is provided with a pivotpin receiving slot312 for receiving a pivot pin314 (SeeFIG. 49) extending between and through a pair ofend plates315 located at a proximal end of anvil half-section114. It is contemplated that a reinforcingmember316 is provided betweenpivot plates310 and is provided with aslot318 corresponding to pivotpin receiving slots312. It is contemplated that reinforcingmember316 can be a separate member or members secured between, or unitarily or integrally formed withpivot plates310.
• Turning now toFIGS. 50-102, another alternative embodiment of a surgical fastener applying apparatus is shown generally as400.Apparatus400 includes a cartridge receiving half-section412, an anvil half-section414 operatively coupled to cartridge receiving half-section412, acartridge assembly416 configured and adapted to be removably mounted within a distal end of cartridge receiving half-section412 and afiring slide410 configured and adapted to be slidably received within cartridge receiving half-section412. As seen inFIGS. 51-53, and as will be described in greater detail below, with cartridge receiving half-section clamping lever430 in an open position, a proximal end of anvil half-section414 is slidably and pivotably receivable at a proximal end of cartridge receiving half-section412. Mountingbosses554, projecting from anvil half-section414, are slidably and pivotably receivable within anaccess channel436aof or defined by cartridge receiving half-section clamping lever430 in order to approximate a distal end of the cartridge receiving and anvil half-sections412,414.
• Referring toFIGS. 56-65, and initially toFIGS. 56 and 57, anvil half-section414 includes an anvil half-section channel member460 having adistal end460aand aproximal end460b.Channel member460 is substantially U-shaped and includes a pair of substantiallyparallel wall portions462.Wall portions462 preferably have adistal portion462ahaving a height which is greater than a height of a proximal portion462bthereof.Wall portions462 preferably are provided withapertures464 formed preferably near or at a mid portion ofchannel member460, here shown as near the proximal end ofdistal portion462athereof, near the change in height fromdistal portion462ato proximal portion462b.Apertures464 are configured and dimensioned to rotatably receive agap adjustment cam470 therein, as will be discussed in greater detail below.
• Anvil half-section414 is provided with ananvil plate544 configured and dimensioned to be fit overwall portions462 ofdistal portion460aof anvil half-section414.Anvil plate544 includes a pair of anvil surfaces546 having a plurality of anvil pockets548 formed therein (seeFIG. 61). Preferably, anvil pockets548 are arranged in two pairs of longitudinal rows.Anvil plate544 includes ananvil knife track547 formed longitudinally therealong.Anvil knife track547 interconnects and separates the pair of anvil surfaces546 from one another.Anvil plate544 includes a pair ofupstanding side walls549 extending upwardly from outside edges of anvil surfaces546 (seeFIGS. 57 and 61). Accordingly, whenanvil plate544 is mounted todistal portion460aof anvil half-section414,side walls549 ofanvil plate544 are preferably disposed along the outside surface ofdistal wall portions462a(seeFIG. 61).
• Anvil half-section414 is further provided with a pair of longitudinally runninganvil reinforcing ribs540 disposed betweenwall portions462 ofdistal portion460a. It is envisioned that each reinforcingrib540 is welded, along anupper edge540athereof, to a lower inside surface ofdistal portion460aofchannel member460. Reinforcingribs540 are preferably welded withinchannel member460 at a position such that reinforcingribs540 are disposed on either side of anvil knife track547 (seeFIG. 61). Reinforcingribs540 strengthendistal portion460aof anvil half-section414 thus reducing the tendency fordistal portion460ato deflect as a result of the stapling forces acting thereon. Reinforcingribs540 preferably have a length substantially equal to a length ofdistal portion460aof anvil half-section414. Eachrib540 is provided with anaperture542 formed near a proximal end thereof. Preferably,apertures542 ofribs540 are in axial and transverse registration withapertures464 formed in thedistal portion462aofwall portions462.
• Anvil half-section414 includes asaddle element550 fixedly secured thereon by welding, gluing, tacking, pinning or the like.Saddle element550 includes abody portion552 having a pair ofproximal legs552aand a pair ofdistal legs552bextending therefrom. Preferably, eachdistal leg552bincludes a mountingboss554 extending outwardly therefrom. Accordingly, whensaddle element550 is mounted onto anvil half-section414, mountingbosses554 are disposed or extend and/or project outwardly from the lateral surfaces ofchannel member460. As will be described in greater detail below, mountingbosses554 assist in the proper and complete operative coupling of cartridge receiving half-section412 with anvil half-section414.
• Anvil half-section414 includes agap adjustment cam470, (seeFIG. 58), operatively disposed inapertures464 formed inwall portions462 ofchannel member460. A cam is herein understood to be a structure having a periphery with at least two different points or areas along the periphery, with each point or area having a different radius from the rotational axis. Cams utilizable in accordance with the present disclosure can be any suitable shape (e.g., triangular, oblong, tear drop and the like).
• As best seen inFIGS. 58, 58A and 58B,gap adjustment cam470 preferably includes a cylindricalforward portion472,cylindrical body portions474 and a cylindricalrearward portion476.Cylindrical body portions474 ofgap adjustment cam470 have a central rotational axis “A” about whichgap adjustment cam470 rotates.Forward portion472 andrearward portion476 preferably share a common axis “B”, spaced a distance “X” from central rotational axis “A” ofbody portions474. Accordingly, asbody portions474 rotate about central rotational axis “A”, forward andrearward portions472,476 act like cams to move one or more objects placed on or engaging forward andrearward portions472,476 through a maximum distance “2X”. While rotation ofgap adjustment cam470 results in a maximum distance of displacement of “2X” it is envisioned thatgap adjustment cam470 can be dimensioned to cause a displacement of any distance upon full or partial rotation thereof.
• While forward andrearward portions472,476 have been shown and described as cylinders, it is envisioned that forward andrearward portions472,476 can take on any other shape (e.g., an oval) which could define a camming surface and which other shape would determine the distance “X” through which the one or more objects placed on or engaging forward andrearward portions472,476 would move. For example, if the camming surface is not a cylinder, e.g., a teardrop shape, then the enlarged or cup portion of the teardrop shape would not be eccentric to axis “A”.
• As seen inFIGS. 58 and 58A,gap adjustment cam470 includes a toothedannular channel478 formed betweenbody portions474.Annular channel478 preferably has a common central axis which is aligned with central axis “A” ofbody portions474. Preferably,annular channel478 has a diameter which is less than a diameter ofbody portions474 such thatteeth480 ofannular channel478 lie below the surface ofbody portions474. Preferably, at least one of forward andrearward portions472,476 is provided with arecess482 formed in an end surface thereof.Recess482 is preferably configured and adapted to complementarily receive a distal end of a rotational tool (not shown) therein. Accordingly,gap adjustment cam470 can be rotated by a rotation of a rotational tool which is operatively received withinrecess482.
• Referring again toFIG. 57 and as seen in greater detail inFIGS. 59 and 61,forward portion472 andrearward portion476 ofgap adjustment cam470 are configured and dimensioned to project outwardly fromapertures464 formed indistal portion462aofwall portions462 ofchannel member460. Preferably,body portion474 ofgap adjustment cam470 is configured and dimensioned to be rotatably disposed withinapertures464. Accordingly, as will be described in greater detail below as seen inFIGS. 54, 55, 64 and 65, when surgicalfastener applying apparatus400 is assembled,forward portion472 andrearward portion476 ofgap adjustment cam470 rest atop ashoulder421 of arespective hinge plate422 extending from cartridge receiving half-section412. In this manner, asgap adjustment cam470 is rotated about common central axis “A” ofbody portions474, forward andrearward portions472,476 press againstshoulder421 ofhinge plate422 asbody portions474 press against an upper surface of eachaperture464 formed indistal portion462aofwall portions462 thereby altering a relative spatial distance between a distal end portion of anvil half-section414 and a distal end portion of cartridge receiving half-section412.
• Gap adjustment cam470 provides surgicalfastener applying apparatus400 with a simple adjustment member whereby a spatial distance or gap “G” (seeFIGS. 64 and 65), between a distal end of anvil half-section414 and a distal end of cartridge receiving half-section412, can be adjusted and set to an accurate predetermined distance regardless of the incoming tolerances or variations resulting from the manufacturing and/or assembly process of the individual components of surgicalfastener applying apparatus400. In other words, gap “G” can be set to a narrow tolerance due to the adjustability provided bygap adjustment cam470 irrespective of whether the individual components of surgicalfastener applying apparatus400 are manufactured with a wide tolerance.
• Gap “G” is measured between the upper face of the distal end portion of cartridge receiving half-section412 and the lower face of the distal end portion of anvil half-section414, preferably withcartridge assembly416 andanvil plate544 in place. By way of reference, the distal end portion is considered that portion of cartridge receiving half-section412 and anvil half-section414 which is distal of the hinge plates and that encompasses or includes the working longitudinal extent or portion of cartridge receiving half-section412 and anvil half-section414.
• As shown inFIG. 57, anvil half-section414 includes a gapadjustment cam lock484. Gapadjustment cam lock484 includes abody portion486 configured and adapted to be mounted to or otherwise secured betweenwall portions462 of anvil half-section channel member460 and adistal end portion488 configured and adapted to engageteeth480 of toothedannular channel478 ofgap adjustment cam470. Preferably,gap adjustment cam470, includingteeth480, is made from a hard metal, such as, for example, stainless steel, whilecam lock484 is made from a pliable material, such as, for example, plastic. Accordingly, whencam lock484 is pressed againstteeth480 ofgap adjustment cam470,teeth480 dig intodistal end portion488 ofcam lock484 and prevent further rotation ofgap adjustment cam470. Alternately,distal end portion488 includes at least onetooth490 configured and dimensioned to snap-fit engageteeth480 of toothedannular channel478 ofgap adjustment cam470. Accordingly,tooth490 ofdistal end portion488 ofcam lock484 preventsgap adjustment cam470 from freely rotating about common central axis “A”. As such,gap adjustment cam470 can be rotated to a plurality of discrete fixed positions corresponding to the positions ofteeth480 of toothedannular channel478. Moreover, a toothed cam lock allowsgap adjustment cam470 to be readjusted after the assembly of surgicalfastener applying apparatus400.
• Referring back toFIG. 57, anvil half-section414 includes aproximal end cap492 configured and dimensioned to be received between a pair offlanges494 provided atproximal end460bof anvil half-section414 (seeFIGS. 59 and 60). A shaped pivot-limitingpin496 is provided therein which extends throughelongated slots498 formed inflanges494 and through a correspondinglyshaped hole500 formed throughdistal end cap492. As will be described in greater detail below, shapedpivot limiting pin496 is substantially “pear or tear-drop shaped” and has abody portion502, having a diameter, about whichpin496 rotates and aneccentric head portion504, having a diameter less than the diameter ofbody portion502, which extends radially outwardly frombody portion502 and which, when inslots498 andhole500, limits the range of rotation ofpin496 about a central axis ofbody portion502.
• Anvil half-section414 further includes adistal end cap506 configured and adapted to be snap-fit into the terminal end509 ofdistal end460aof anvil half-section414. Preferably,distal end cap506 is tapered in shape in order to facilitate insertion ofdistal end460aof anvil half-section414 into the target surgical site.
• With reference toFIG. 56 and also particularly toFIGS. 66-86, cartridge receiving half-section412 of surgical fastener applying apparatus is shown and described. Cartridge receiving half-section412 includes a removable and disposablestaple cartridge assembly416.Staple cartridge assembly416 includes acartridge body418, a plurality of staple pushers attached to each other in groups of two offset oriented pusher pairs423, abottom cover422, aknife424, having an angled sharpenedleading edge424aand an atraumaticforward tip424c, a plurality ofstaples426, a pivotably mountedsafety lockout428 and aremovable shipping wedge431. As with known staple cartridge designs,cartridge body418 has a plurality of rows ofstaple retaining slots432 formed therein. As seen inFIG. 67, in this embodiment, there are two staggered rows ofslots432 formed on either side of a linear slottedtrack434 which guidesknife424 during its longitudinal movement. Asingle staple426 is positioned in each ofslots432.
• As seen inFIG. 67, pusher pairs423 are arranged in two series, one series on each side of slottedtrack434, such that the center line of pusher pairs423 of each series of pusher pairs423 forms a line centered between the staggered rows ofstaples426. The actuating surfaces of pusher pairs423 act as cam followers and interact with a pair of staggered camming surfaces436 and438 extending from a pair of cam bars440 (seeFIGS. 56, 69-70) to expel the pairs ofstaples426 on each side ofknife track434. As illustrated, camming surfaces436 and438 form a single angle relative to horizontal as eachcam bar440 is moved distally. Cam bars440 are moved distally until they are either stopped intentionally by the user to form less than all ofstaples426, or until all ofstaples426 are expelled fromcartridge assembly416.
• As seen inFIG. 67,bottom cover425 partially encloses the bottom of a channel formed by the upper surface and side walls ofcartridge body418. Alongitudinal ridge425ais formed on an upper surface ofbottom cover425 and serves as a bearing surface forknife bearing channel442, which channel is secured to the bottom edge ofknife424, as knife travels inknife track434.Knife bearing channel442 which is preferably wider thanknife track434, is secured to the bottom surface ofknife424 such that knife bearingchannel member442 rides betweenknife track434 andlongitudinal ridge425aofbottom cover425. In this manner,knife424 is prevented from undergoing substantial vertical movement during longitudinal translation inknife track434.
• As seen inFIGS. 67 and 68,safety lockout428 is pivotably disposed on the upper proximal end ofcartridge body418 and is movable from a locked orientation to an unlocked orientation. Preferably,safety lockout428 is biased away from the locked orientation towards an orientation substantially perpendicular to the longitudinal axis ofcartridge body418. Any suitable biasing member may be utilized such as, for example,spring444. To overcome the bias towards the perpendicular orientation,safety lockout428 includes an upper transversehorizontal surface428a(seeFIGS. 67, 68, 76, 88, 93 and 98-102) extending from the underside thereof which engages the undersurface of a hook424bformed on the upper edge surface ofknife424. This cooperative engagement serves to retainsafety lockout428 in the locked orientation whensafety lockout428 coversknife424.
• Whensurgical stapler400 has been unclamped, as will be described in greater detail further herein, after either partial or complete firing,safety lockout428 is biased to the perpendicular orientation (seeFIGS. 99-102), extending upwardly away from cartridge receiving half-section412. In this manner,safety lockout428 preventssurgical stapler400 from being re-clamped until the partial or completely firedcartridge assembly416 is removed and replaced with anew cartridge assembly416.
• Similar tosurgical stapler100 ofFIGS. 2-21, oncesurgical stapler400 has been at least partially fired, and if the instrument is opened,safety lockout428 ofcartridge assembly416 automatically moves to the perpendicular orientation due to the spring bias mounting thereof. Withsafety lockout428 in this orientation,surgical stapler400 cannot be re-clamped in order to continue or to complete the firing. Thus, if the user desires to apply further staples, the partially firedcartridge assembly416 must first be removed and replaced with a new ornon-fired cartridge assembly416.
• As previously described with reference to surgicalfastener applying apparatus100,shipping wedge431 is removably attachable tocartridge body418 and is configured and dimensioned to cover the entire surface area ofstaple rows426 andknife track434.
• Referring toFIG. 76, a loading andlockout mechanism451 forcartridge assembly416 will now be described in detail. Loading andlockout mechanism451 facilitates loading ofcartridge assembly416 and prevents firing ofsurgical stapler400 untilcartridge assembly416 is properly loaded on cartridge receiving half-section412 andsurgical stapler400 is properly clamped shut. Loading andlockout mechanism451 includes arocker452 which rests atop cartridge receiving half-section412. As seen inFIG. 76,rocker452 preferably includes three slots, namely, open bottom slots452b,452cto permit longitudinal movement ofcam bar channel440 of firingslide410 and a closed central slot452dto permit passage of aknife actuating bar454 therethrough.
• Rocker452 of surgical fastener applying apparatus functions in the same manner asrocker152 of surgicalfastener applying apparatus100.Rocker452 is biased, by way of a spring456 which is disposed on transversely extending post portions452aand between a ridge452fformed on a side of therocker452 and an upper surface of cartridge receivinghalf section412, downwardly toward a locked-out position. When in the locked-out position,rocker452 prevents cam bars440 from distal longitudinal movement. In addition, when in the locked-out position, as seen inFIG. 88, aproximal edge surface452gofrocker452 engages anotch454aformed in an upper edge ofknife actuating bar454 in order to prevent distal longitudinal movement ofknife actuating bar454. As best shown inFIG. 88,rocker452 is further provided with a downwardly extendingblocking surface452ewhich is in vertical alignment with anopening440aformed through the bottom surface of eachcam bar440 when eachcam bar440 is in its proximal-rest position
• Upon joining anvil half-section414 with cartridge receiving half-section412, as seen inFIGS. 76, 87, 88 and 93,rocker452 is urged to rotate as indicated by arrow “D” inFIG. 93 by the lower surface of anvil half-section414, and inparticular cam lock484, pressing against the upper surface ofrocker452. In this manner, proximal upperedge blocking surface452gis moved out of (i.e., pivoted out of) engagement withnotch454aofknife actuating bar454 thereby permitting a distal longitudinal movement ofknife actuating bar454 through slot452d.
• As seen inFIGS. 67 and 76, one of a pair ofresilient friction fingers419 is provided on either side ofcartridge body418 near a proximal end thereof.Friction fingers419 are configured and adapted to project outwardly fromcartridge body418 and to frictionally engage the inner surface ofdistal side walls420a(seeFIG. 77) of cartridge receiving half-section channel member420. In this manner,friction fingers419 preventcartridge assembly416 from falling out of cartridge receiving half-section412.
• As seen inFIGS. 56 and 69-71, firingslide410 includes a pair of camming surfaces436,438 extending from a pair of cam bars440 which are joined to one another at a proximal end thereof, aknife actuating bar454 positioned between the pair of cam bars440, aslide block588 operatively associated with the proximal end of the pair of cam bars440, and afiring lever465 pivotably coupled to slideblock588. Firinglever465 provides the user with the ability to fire surgicalfastener applying apparatus400 from either the left or the right side. As seen inFIG. 70 and in greater detail inFIG. 88,knife actuating bar454 includes ahook454aformed at a distal end thereof.Hook454aofknife actuating bar454 is configured and adapted to engage ahook424dformed at the proximal end ofknife424. In this manner, asknife actuating bar454 is displaced proximally and distally, so to isknife424.
• Slide block588 includes ahub590 projecting therefrom and configured and adapted to be snap-fit into apivot hole592 formed inlever465.Slide block588 further includes a pedal594 reciprocally received with ahole596 formed inslide block588. As seen inFIG. 71,pedal594 includes asplit body portion594a, configured and adapted to straddle a proximal end ofknife actuating bar454, and apin594cextending upwardly therefrom. Preferably,body portion594aincludes an angled distal surface594b. Preferably, pin594cis configured and dimensioned to extend completely throughhole596 ofslide block588. As seen inFIG. 70, acompression spring598 is disposed aboutpin594cand betweensplit body portion594aofpedal594 andslide block588. In this manner,pedal594 is biased away fromslide block588.
• As seen inFIGS. 74 and 75, firinglever465 includes anarcuate recess465aformed in a bottom surface thereof.Arcuate recess465adefines the range of rotation through which firing slide465 can pivot abouthub590 ofslide block588. Firinglever465 further includes astop recess465bformed at each end ofarcuate recess465a. As will be described in greater detail below, stoprecesses465bare configured and dimensioned to receive a distal end ofpin594cofpedal594 therein in order to prevent firinglever465 from pivoting abouthub590 during a firing stroke of surgicalfastener applying apparatus400.
• Turning toFIGS. 56 and 76-86, cartridge receiving half-section412 of surgicalfastener applying apparatus400 includes a cartridge receiving half-section channel member420, a cartridge receiving half-section lever430 pivotably coupled tochannel420, a cartridge lever release member520 (seeFIG. 85) operatively coupled to a proximal end ofcartridge lever430, and a contouredcartridge lever cover530 configured and adapted to snap-fit overcartridge lever430.
• As seen inFIGS. 77 and 78, cartridge receiving half-section channel member420 includes a pair of juxtaposedhinge plates422 extending upwardly from the sides thereof. Preferably, hingeplates422 are spaced a distance apart sufficient to permit anvil half-section channel member460 to be received therebetween. Turning momentarily back toFIG. 51, eachhinge plate422 includes a substantiallyU-shaped slot424 formed through an upper edge thereof for permitting receipt of a respective mounting nub orboss554 ofsaddle element550 therein. Eachhinge plate422 further includes ashoulder426 formed at a proximal end thereof.Shoulders426 define a substantially planarhorizontal surface426aon which forward andrearward portions472,476 ofgap adjustment cam470 rests (seeFIGS. 64 and 65).
• Apivot bracket428 is secured to a bottom surface of cartridge receiving half-section channel member420.Pivot bracket428 includes anannular portion428aconfigured and adapted to receive apivot pin432 therethrough (seeFIG. 56).
• Cartridge receiving half-section channel member420 further includes a pair of juxtaposedpivot plates510 extending upwardly from a proximal end thereof. Eachpivot plate510 is provided with a pivotpin receiving slot512 for receiving shapedpivot limiting pin496 of anvil half-section414 therein (seeFIG. 52). As seen inFIG. 78, cartridge receiving half-section channel member420 further includes acartridge lever latch514 formed at a proximal end thereof.
• Turning now toFIGS. 83 and 84, clampinglever430 includes abody portion434 having a pair of juxtaposedhinge plates436 extending upwardly from a distal end thereof and a pair of juxtaposedpin receiving brackets438 extending downwardly from a distal end thereof. Eachpin receiving bracket438 is provided with apin receiving hole438aformed therein for receiving the ends of pivot pin432 (seeFIG. 56) therein.
• Eachhinge plate436 is provided with anaccess channel436aformed therein. A portion of one channel cover for anaccess channel436ais shown broken away. Preferably, eachaccess channel436ahas a first portion436bwhich is oriented substantially vertically when clampinglever430 is in an open position (seeFIG. 51) and asecond portion436cwhich is oriented substantially horizontally when clampinglever430 is being moved to and is in a closed position (seeFIGS. 64 and 65). Eachaccess channel436ais configured and adapted to slidably receive a respective mountingboss554 ofsaddle550 therein, which mountingbosses554 extend and project from the lateral surface of anvil half-section channel member460 a distance sufficient to engage eachaccess channel436aand have a cross-sectional dimension enabling it to be received within eachaccess channel436a. Preferably,access channels436aare covered in order to prevent tissue from being trapped withinaccess channels436aand in order to provide additional strength to eachhinge plate436.
• As seen inFIGS. 56 and 81, cartridgelever release member520 is spring biased proximally toward a lateral position via aspring member522 and is provided with a catch524 (seeFIGS. 81 and 90) for engaging cartridge lever latch514 (seeFIG. 94) formed at the proximal end of cartridge receiving half-section channel member420. In order to releasecartridge lever latch514, the user pressesrelease member520 in a distal direction, thereby disengagingcatch524 fromlatch514.
• In order to prevent inadvertent opening of clampinglever430, as seen inFIGS. 81 and 85,release member520 is provided with aprojection520aextending downwardly from a proximal end thereof, whichprojection520ais seated within aguard532 formed at a proximal end ofcartridge lever cover530.
• Cartridge receiving half-section412 is further provided with aleaf spring534 as seen inFIGS. 56 and 79, having aproximal end534asecured to an inside of clampinglever430, via apost member536, and a freedistal end534bcontacting a bottom surface of cartridge receiving half-section channel member420. In this manner, clampinglever430 is spring biased away from cartridge receiving half-section channel member420.
• With reference toFIGS. 64-65 and 87-102, use and operation of surgicalfastener applying apparatus400 is shown and described. Initially, with reference toFIGS. 64 and 65, after assembly of most, if not at all of the individual components of surgicalfastener applying apparatus400, gap “G” can be set (seeFIG. 65). According to one method of setting gap “G”, a gauging element, such as, for example, a feeler gauge, (not shown) having a predetermined fixed thickness is inserted into gap “G” between the distal ends of cartridge receiving half-section412 and anvil half-section414, preferably between tissue contacting surfaces ofcartridge assembly416 and ofanvil544.Gap adjustment cam470 is fixed or rotated and fixed, causing cartridge receiving half-section412 and/or anvil half-section414 to displace relative to one another, until gap “G” is set to the predetermined thickness of the gauging element.Gap adjustment cam470 is adjusted until cartridge receiving half-section412 and anvil half-section414 contact the gauging element. As seen inFIG. 65, rotation ofgap adjustment cam470, as indicated by arrow “C” results in rotation of, for example, anvil receiving half-section414, about pivot point “Y” (i.e., mounting bosses554), in the direction indicated by arrow “C1”. Accordingly, gap “G” will be narrower at the distal tip and will become progressively wider from the distal tip towardshinge plates422, such that in the loaded condition, with tissue present, deflection will occur at the tip to create a more uniform gap along the overall distal portion of surgicalfastener applying apparatus400.
• Once the position ofgap adjustment cam470 is fixed or set,gap adjustment cam470 is fixedly held in position bycam lock484 such that further rotation ofgap adjustment cam470 is prevented. While the adjustment and the setting of gap “G” is a step which preferably takes place during the manufacture and assembly of surgicalfastener applying apparatus400, it is envisioned that the adjustment and setting of gap “G” can take place post manufacturing and assembly, including by a user, but preferably prior to packaging or use of the stapler. Other suitable means and methods for adjusting gap “G” can be employed at the same time or other times during or as part of the manufacturing or assembly process. It is envisioned that adjustment of the size of gap “G”, such as, for example, during the manufacturing and assembly process, allows for the manufacture of surgical fastener applying apparatus which can be set to varying predetermined gap sizes in order to accommodate cartridge assemblies having different length staples therein. In other words, if a cartridge assembly having relatively shorter length staples is to be used, the gap can be set to a narrower dimension. Alternatively, if a cartridge assembly having relatively longer length staples is to be used, the gap can be set to a larger dimension.
• One method or sequence of coupling and closure of cartridge receiving half-section412 with anvil half-section414 is best seen inFIGS. 87-91. Withcartridge lever430 in an open position, as seen inFIGS. 51, 52 and 87, the proximal ends of half-section412,414 are approximated toward one another such thatpivot limiting pin496 of anvil half-section414 rests within pivotpin receiving slots512 ofpivot plates510 of cartridge receiving half-section412. As best seen inFIG. 91, the shape ofpivot limiting pin496 limits the longitudinal angle (i.e., the angle between cartridge receiving half-section412 and anvil half-section414) at which anvil half-section414 can be coupled with cartridge receiving half-section412 to an angle “α”. Preferably, angle “α” is about 15°. With the proximal ends of half-section412,414 coupled to one another, the distal ends of half-section412,414 are approximated towards one another until mountingbosses554, projecting from anvil half-section414, are received within first portion436bofaccess channels436aformed on clampinglever430. Alternatively, the distal ends or mid portions of half-sections412,414 can be coupled to one another before the proximal ends are joined to one another. It is also further envisioned that the proximal and distal ends of half-sections412,414 can be simultaneously coupled to one another.
• With mountingbosses554 positioned withinaccess channels436aof cartridge lever430 (seeFIGS. 51, 64 and 65), the proximal end of clampinglever430 is approximated toward cartridge receiving half-section412 untilcatch524 ofrelease member520 engageslatch514 of cartridge receiving half-section channel member420 (seeFIG. 94). By approximating clampinglever430 toward cartridge receiving half-section412, mountingbosses554 are advanced throughaccess channels436a(i.e., from first portion436btosecond portion436c, as seen inFIG. 64) thereby completing the approximation of cartridge receiving half-section412 with anvil half-section414, as a result of the camming action taking place therebetween.
• As seen inFIGS. 92-94, complete approximation of half-sections412,414 to one another results in the disengagement ofrocker452 from firingslide410, includingcam bar440 andknife actuating bar454, as evidenced by arrow “D” inFIG. 93. In particular,proximal edge surface452gofrocker452 disengages notch454aofknife actuating bar454 and blockingsurface452edisengages opening440aformed incam bar440. Withrocker452 disengaged fromknife actuating bar454 andcam bar440, the user is now able to fire surgicalfastener applying apparatus400 by drivingfiring slide410 distally.
• Firing slide410 is driven distally by advancingfiring lever465 in a distal direction, as indicated by arrow “E” ofFIG. 95. As seen inFIGS. 94 and 98, distal advancement of firinglever465 results inpedal594 rising up due to the camming action of angled distal surface594bofbody portion594aagainst cartridge receiving half-section channel member420. In so doing, the distal end ofpin594cis received in astop recess465b(seeFIGS. 74 and 75) of firinglever465 in order to prevent firinglever465 from rotating abouthub590 ofslide block588.
• As seen inFIGS. 93 and 98, distal advancement of firingslide410 also results in the disengagement of transversehorizontal surface428aofsafety lockout428 from hook424bformed on the upper edge surface ofknife424. Accordingly, when surgicalfastener applying apparatus400 is unclamped, after either partial or complete firing,safety lockout428 is biased to the perpendicular orientation (seeFIGS. 99-102), extending upwardly away from cartridge receiving half-section412. In this manner,safety lockout428 prevents surgicalfastener applying apparatus400 from being re-clamped until partial or completely firedcartridge assembly416 is removed and replaced with anew cartridge assembly416.
• It is envisioned that any of the surgical fastener applying apparatus disclosed herein can be configured and adapted to receive a staple cartridge loaded with a plurality of directionally biased staples and/or specially configured axial pockets as disclosed in commonly assigned U.S. patent application Ser. No. 09/972,594, filed Oct. 5, 2001 which is a Continuation-in-Part application of U.S. Ser. No. 09/693,379, field Oct. 20, 2000, both of which are entitled “Directionally Biased Staple and Method of Manufacture”, the entire contents of each of which are incorporated herein by reference.
• It will be understood that various modifications may be made to the embodiments of the surgical fastener applying apparatus disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

Claims (10)

1. A method of adjusting a staple gap in a surgical stapling apparatus, the method comprising:

providing a surgical stapling apparatus having a jaw structure with an anvil receiving portion and a jaw structure with a cartridge receiving portion, the jaw structures being operatively couplable to one another to provide a staple gap between forward portions of the anvil and cartridge receiving portions;

positioning a gap adjustment member between the jaw structures;

rotating the gap adjustment member to provide a staple gap between the forward portions of the anvil and cartridge receiving portions; and

locking the gap adjustment member in a radial position to fix a size of the staple gap.

2. The method according toclaim 1, wherein one of the jaw structures includes a pair of mounting members thereon for mounting the other of the jaw structures thereon, the method comprising positioning the gap adjustment member on the mounting members between the jaw structures.

3. The method according toclaim 1, wherein the gap adjustment member includes one or more bearing portions sharing a common rotational axis, and one or more cam surface portions having a periphery with at least two different points along the periphery, with each point along the periphery having a different radius from the rotational axis, wherein rotating the gap adjust member results in a varying of the size of the staple gap.

4. The method according toclaim 3, wherein the cam surface portions define a central axis parallel to, and spaced a distance from, the rotational axis of the bearing portions.

5. The method according toclaim 4, wherein the rotating the gap adjustment member results in a movement of the jaw structures relative to one another in a direction transverse to a longitudinal axis defined by one of the jaw structures.

6. A method of adjusting a staple gap, the method comprising:

positioning a gap adjustment member between an anvil receiving portion and a cartridge receiving portion, the anvil receiving portion and the cartridge receiving portion operatively couplable to one another;

rotating the gap adjustment member to adjust a size of a staple gap between the anvil and cartridge receiving portions; and

locking the gap adjustment member in a radial position to fix the size of the staple gap between the anvil and cartridge receiving portions.

7. The method according toclaim 6, further comprising positioning the gap adjustment member on mounting members of one of the anvil receiving portion or the cartridge receiving portion.

8. The method according toclaim 6, wherein rotating the gap adjustment member results in a varying of the size of the staple gap, and wherein the gap adjustment member includes one or more bearing portions sharing a common rotational axis, and one or more cam surface portions having a periphery with at least two different points along the periphery, each point along the periphery having a different radius from the common rotational axis.

9. The method according toclaim 8, wherein the cam surface portions define a central axis parallel to, and spaced a radial distance from, the rotational axis of the bearing portions.

10. The method according toclaim 9, wherein rotating the gap adjustment member results in a movement of the anvil and cartridge receiving portions relative to one another in a direction transverse to a longitudinal axis defined by one of the anvil and cartridge receiving portions.

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